Device recall: ANGIODRAPE PK 4/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound…
Class II FDA enforcement event 71721. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Customed, Inc started this device recall on 10 Jul 2015. The firm address in the FDA record is in Fajardo, PR. FDA put the recall in Class II. FDA event 71721 has 170 product records. The first FDA enforcement report date is 9 Sep 2015. The record gives the status Terminated, with the termination date 12 Apr 2017.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Distributed Only in Puerto Rico.
Recalling firm
Customed, Inc, Fajardo, PR.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
170 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2548-2015 | ANGIODRAPE PK 4/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. | 192 packs | Class II | Terminated | 9 Sep 2015 |
| Z-2549-2015 | SUTURE REMOVAL KIT CUSTOMED 100/CS Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. | 20200 kits | Class II | Terminated | 9 Sep 2015 |
| Z-2550-2015 | O.B. PK 4/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. | 48 packs | Class II | Terminated | 9 Sep 2015 |
| Z-2551-2015 | IRRIGATION TRAY W/BULB SYRINGE CUSTOMED 50/CS Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. | 4800 trays | Class II | Terminated | 9 Sep 2015 |
| Z-2552-2015 | LAPAROSCOPY PK 3/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. . | 339 packs | Class II | Terminated | 9 Sep 2015 |
| Z-2553-2015 | UNIVERSAL DRAINAGE TRAY CUSTOMED 20/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. . | 960 trays | Class II | Terminated | 9 Sep 2015 |
| Z-2554-2015 | MAJOR LAPAROTOMY PK 4/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. . | 1084 packs | Class II | Terminated | 9 Sep 2015 |
| Z-2555-2015 | MINOR PROCEDURE PACK 40/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. . | 80 packs | Class II | Terminated | 9 Sep 2015 |
| Z-2556-2015 | WOUND CLOSURE TRAY I CUSTOMED 50/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. . | 8050 trays | Class II | Terminated | 9 Sep 2015 |
| Z-2557-2015 | WOUND CLOSURE TRAY II CUSTOMED 50/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. . | 1350 trays | Class II | Terminated | 9 Sep 2015 |
| Z-2558-2015 | CYSTO TUR PACK CUSTOMED 10/CS REV. C 10/13 NON STERILE Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. . | 290 packs | Class II | Terminated | 9 Sep 2015 |
| Z-2559-2015 | OB PACK CS/4 Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. . | 96 packs | Class II | Terminated | 9 Sep 2015 |
| Z-2560-2015 | ARTHROSCOPY PACK 3/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. . | 45 packs | Class II | Terminated | 9 Sep 2015 |
| Z-2561-2015 | LAPAROSC CHOLE 3/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. . | 426 kits | Class II | Terminated | 9 Sep 2015 |
| Z-2562-2015 | PERI GYN PACK CS/6 Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. . | 228 packs | Class II | Terminated | 9 Sep 2015 |
| Z-2563-2015 | ARTHROSCOPY PK CS/4 Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. . | 180 packs | Class II | Terminated | 9 Sep 2015 |
| Z-2564-2015 | PERY GYN PACK CUSTOMED 10/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. . | 460 packs | Class II | Terminated | 9 Sep 2015 |
| Z-2565-2015 | TRACHEOTOMY CARE KIT CUSTOMED 50/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. . | 3550 kits | Class II | Terminated | 9 Sep 2015 |
| Z-2566-2015 | FOLEY CATHETER KIT II 16FR. CUSTOMED 20/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. . | 1960 kits | Class II | Terminated | 9 Sep 2015 |
| Z-2567-2015 | FOLEY CATHETER KIT II 18 FR 20/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. . | 280 kits | Class II | Terminated | 9 Sep 2015 |
| Z-2568-2015 | NEURO PACK 3/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. . | 15 packs | Class II | Terminated | 9 Sep 2015 |
| Z-2569-2015 | WOUND MANAG.TRAY 24/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. . | 1248 trays | Class II | Terminated | 9 Sep 2015 |
| Z-2570-2015 | LAPAROSCOPY PACK 6/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. . | 138 packs | Class II | Terminated | 9 Sep 2015 |
| Z-2571-2015 | LAPAROSC. OB GYN PK 5/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. . | 95 packs | Class II | Terminated | 9 Sep 2015 |
| Z-2572-2015 | OPEN HEART TRAY 1/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. . | 106 trays | Class II | Terminated | 9 Sep 2015 |
| Z-2573-2015 | WOUND MANAGEMENT TRAY II 30/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. . | 690 trays | Class II | Terminated | 9 Sep 2015 |
| Z-2574-2015 | LAMINECTOMY PACK 3/C Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. . | N/A | Class II | Terminated | 9 Sep 2015 |
| Z-2575-2015 | PREMIUM CESAREAN PACK CUSTOMED 5/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. . | 25 packs | Class II | Terminated | 9 Sep 2015 |
| Z-2576-2015 | PREMIUM LAPAROTOMY PK CUSTOMED 6/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. . | 508 packs | Class II | Terminated | 9 Sep 2015 |
| Z-2577-2015 | PREMIUM O.B. PACK CUSTOMED 5/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. . | 390 packs | Class II | Terminated | 9 Sep 2015 |
| Z-2578-2015 | PREMIUM ARTHROSCOPY PK CUSTOMED 5/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. . | 55 packs | Class II | Terminated | 9 Sep 2015 |
| Z-2579-2015 | NEURO SPINE PACK 3/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. . | 123 packs | Class II | Terminated | 9 Sep 2015 |
| Z-2580-2015 | PEDIATRIC LAP PACK 8/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. . | 48 packs | Class II | Terminated | 9 Sep 2015 |
| Z-2581-2015 | OPEN HEART TRAY 1/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. . | 56 trays | Class II | Terminated | 9 Sep 2015 |
| Z-2582-2015 | PLASTIC SURGERY PACK 5/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. . | 55 packs | Class II | Terminated | 9 Sep 2015 |
| Z-2583-2015 | UMBILICAL VESSEL CATHETER KIT CUSTOMED 8/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. . | 48 kits | Class II | Terminated | 9 Sep 2015 |
| Z-2584-2015 | WOUND MANAGEMENT CUSTOMED 20/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. . | 580 | Class II | Terminated | 9 Sep 2015 |
| Z-2585-2015 | UROLOGY CUSTOMED PACK 5/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. . | 130 packs | Class II | Terminated | 9 Sep 2015 |
| Z-2586-2015 | IMPLANTE DE ORTHOPEDIA 3/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. . | 81 | Class II | Terminated | 9 Sep 2015 |
| Z-2587-2015 | E.N.T. PK 7/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. . | 63 | Class II | Terminated | 9 Sep 2015 |
| Z-2588-2015 | ANGIOGRAPHY PK 5/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. . | 130 | Class II | Terminated | 9 Sep 2015 |
| Z-2589-2015 | D & C LAPAROSCOPY PK 4/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. . | 192 | Class II | Terminated | 9 Sep 2015 |
| Z-2590-2015 | LAPAROTOMY PK 4/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. . | 1072 | Class II | Terminated | 9 Sep 2015 |
| Z-2591-2015 | FOLEY CATH KIT 16FR. W/FOLEY S SENSOR 20/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. . | 160 | Class II | Terminated | 9 Sep 2015 |
| Z-2592-2015 | UROLOGY PACK 4/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. . | 352 | Class II | Terminated | 9 Sep 2015 |
| Z-2593-2015 | DRESSING CHANGE CUSTOMED 50/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. . | 1050 | Class II | Terminated | 9 Sep 2015 |
| Z-2594-2015 | LEGGINGS W/7" CUFF 30" x 42" 30/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. . | 300 | Class II | Terminated | 9 Sep 2015 |
| Z-2595-2015 | Gown, surgical 30/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. . | 180 | Class II | Terminated | 9 Sep 2015 |
| Z-2596-2015 | UNIVERSAL PACK 3/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. . | 27 | Class II | Terminated | 9 Sep 2015 |
| Z-2597-2015 | RETINA PACK 7/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. . | 21 | Class II | Terminated | 9 Sep 2015 |
| Z-2598-2015 | FEMORAL PACK 5/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. . | 320 | Class II | Terminated | 9 Sep 2015 |
| Z-2599-2015 | LAPAROS.CHOLE 3/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. . | 120 | Class II | Terminated | 9 Sep 2015 |
| Z-2600-2015 | CESAREAN PACK 3/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. . | 96 | Class II | Terminated | 9 Sep 2015 |
| Z-2601-2015 | LABOR & DELIVERY 4/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. . | 344 | Class II | Terminated | 9 Sep 2015 |
| Z-2602-2015 | OPEN HEART TRAY CUSTOMED 1/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. . | 37 | Class II | Terminated | 9 Sep 2015 |
| Z-2603-2015 | PERI GYN PACK 10/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. . | 80 | Class II | Terminated | 9 Sep 2015 |
| Z-2604-2015 | O.B. PACK 4/CS REV. Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. . | 132 | Class II | Terminated | 9 Sep 2015 |
| Z-2605-2015 | CESAREAN PACK 4/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. . | 104 | Class II | Terminated | 9 Sep 2015 |
| Z-2606-2015 | MINOR LAP. PACK 5/CS REV. Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. . | 945 | Class II | Terminated | 9 Sep 2015 |
| Z-2607-2015 | UROLOGY PK 5/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. . | 10 | Class II | Terminated | 9 Sep 2015 |
The table shows 60 of 170 product records. The FDA enforcement report lists all the records.
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2015
- 1,153
- Share of these events in Class II
- 91%
- Product records in this event
- 170Median of the firm: 179
- Events of the firm on the register
- 4
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 7 Jan 2016 | Catalog Number: 9001771 MAYO STAND COVER STERILE Used by medical staff to perform surgical procedures and patient care p | Device | Class II | 100 |
| 8 Oct 2014 | Surgical packs (includes trays, bags and kits) Used by medical staff to perform patient care procedures such as wound he | Device | Class I | 179 |
| 20 May 2014 | Customed Angiodrape Pack convenience pack include multiple components: syringe 10cc and 30cc, gauze, denture cup, specim | Device | Class I | 233 |
Official channels
- FDA enforcement report Z-2548-2015The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 71721. https://recallregister.com/fda/ii/71721/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Distributed Only in Puerto Rico.
- What quantity of product is in FDA event 71721?
- The event has 170 product records. The first record gives this quantity:
192 packs
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2015 have the same class?
- 91% of the 1,153 device events that started in 2015 are in Class II.