Device recall: Surgical packs (includes trays, bags and kits) Used by medical staff to perform patient care procedures such as wound…
Class I FDA enforcement event 69448. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.
Class I, in the words of FDA
a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death
Customed, Inc started this device recall on 8 Oct 2014. The firm address in the FDA record is in Fajardo, PR. FDA put the recall in Class I. FDA event 69448 has 179 product records. The first FDA enforcement report date is 10 Dec 2014. The record gives the status Terminated, with the termination date 14 Aug 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.
US Distribution to Florida, New York and 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
179 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0237-2015 | Surgical packs (includes trays, bags and kits) Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. | 185000 | Class I | Terminated | 10 Dec 2014 |
| Z-0238-2015 | Irrigation Tray With Bulb Syringe, Catalog number 900-020. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. | 76800 | Class I | Terminated | 10 Dec 2014 |
| Z-0239-2015 | Universal Drainage Tray, Catalog number 900-032. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. | 8000 | Class I | Terminated | 10 Dec 2014 |
| Z-0240-2015 | Wound Closure Tray I, Catalog number 900-063. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. | 66250 | Class I | Terminated | 10 Dec 2014 |
| Z-0241-2015 | Wound Closure Tray II, Catalog number 900-064. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. | 12300 | Class I | Terminated | 10 Dec 2014 |
| Z-0242-2015 | Tracheotomy Care Kit, Catalog number 900-110. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. | 78600 | Class I | Terminated | 10 Dec 2014 |
| Z-0243-2015 | Suction Catheter Kit, Catalog number 900-277. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. | 134160 | Class I | Terminated | 10 Dec 2014 |
| Z-0244-2015 | Uretheral Catheter Tray, Catalog number 900-278. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. | 50950 | Class I | Terminated | 10 Dec 2014 |
| Z-0245-2015 | Surgeon Reinforced Gown XL, Catalog number 900-521. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. | 89284 | Class I | Terminated | 10 Dec 2014 |
| Z-0246-2015 | Surgeon Gown Poly Reinforced Lgc, Catalog number 900-522. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. | 86912 | Class I | Terminated | 10 Dec 2014 |
| Z-0247-2015 | Wound Management Tray Ill, Catalog number 900-540. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. | 13680 | Class I | Terminated | 10 Dec 2014 |
| Z-0248-2015 | Utility Drape End Product, Catalog number 900-582. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. | 9700 | Class I | Terminated | 10 Dec 2014 |
| Z-0249-2015 | Incision & Drainage Tray, Catalog number 900-774. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. | 9200 | Class I | Terminated | 10 Dec 2014 |
| Z-0250-2015 | Skin Staple Removal, Catalog number 900-782. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. | 20960 | Class I | Terminated | 10 Dec 2014 |
| Z-0251-2015 | Wound Management Tray, Catalog number 900-1154. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. | 27024 | Class I | Terminated | 10 Dec 2014 |
| Z-0252-2015 | Wound Management Tray II, Catalog number 900-1198. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. | 28020 | Class I | Terminated | 10 Dec 2014 |
| Z-0253-2015 | Gown Surgical Non Reinforced XL, Catalog number 900-1579. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. | 4710 | Class I | Terminated | 10 Dec 2014 |
| Z-0254-2015 | Wound Management Tray Ryder Memorial, Catalog number 900-1456. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. | 23300 | Class I | Terminated | 10 Dec 2014 |
| Z-0255-2015 | Leggings W/7'' Cuff, Catalog number 900-1574. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. | 3540 | Class I | Terminated | 10 Dec 2014 |
| Z-0256-2015 | Minor Laceration Tray, Catalog number 900-1765. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. | 66200 | Class I | Terminated | 10 Dec 2014 |
| Z-0257-2015 | Mayo Stand Cover W/CSR Wrap, Catalog number 900-1771. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. | 10090 | Class I | Terminated | 10 Dec 2014 |
| Z-0258-2015 | Wound Management Tray, Catalog number 900-1903. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. | 4000 | Class I | Terminated | 10 Dec 2014 |
| Z-0259-2015 | Gown Surg Fully Impervious Large, Catalog number 900-2564. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. | 170 | Class I | Terminated | 10 Dec 2014 |
| Z-0260-2015 | Gown Surgical Poly Reinforced XL X-Long, Catalog number 900-2565. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. | 2640 | Class I | Terminated | 10 Dec 2014 |
| Z-0261-2015 | Gown Surgical Non Reinforced XXL, Catalog number 900-2566. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. | 2520 | Class I | Terminated | 10 Dec 2014 |
| Z-0262-2015 | Gown Fabric Reinforced XXL, Catalog number 900-2567. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. | 1120 | Class I | Terminated | 10 Dec 2014 |
| Z-0263-2015 | Gown Surgical Fabric Reinforced XL, Catalog number 900-2568. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. | 2240 | Class I | Terminated | 10 Dec 2014 |
| Z-0264-2015 | Gown Surgical Fabic Reinforced Large, Catalog number 900-2569. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. | 2670 | Class I | Terminated | 10 Dec 2014 |
| Z-0265-2015 | Angiodrape Pack, Catalog number 900-002. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. | 1152 | Class I | Terminated | 10 Dec 2014 |
| Z-0266-2015 | O.B. Pack, Catalog number 900-012. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. | 176 | Class I | Terminated | 10 Dec 2014 |
| Z-0267-2015 | Laparoscopy Pack, Catalog number 900-028. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. | 1152 | Class I | Terminated | 10 Dec 2014 |
| Z-0268-2015 | Major Laparotomy Pack, Catalog number 900-036. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. | 840 | Class I | Terminated | 10 Dec 2014 |
| Z-0269-2015 | Cysto Tur Pack, Catalog number 900-080. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. | 380 | Class I | Terminated | 10 Dec 2014 |
| Z-0270-2015 | OB Pack, Catalog number 900-1030. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. | 224 | Class I | Terminated | 10 Dec 2014 |
| Z-0271-2015 | Arthroscopy Pack, Catalog number 900-1042. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. | 180 | Class I | Terminated | 10 Dec 2014 |
| Z-0272-2015 | Laparoscopy Chole Pack, Catalog number 900-1059. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. | 480 | Class I | Terminated | 10 Dec 2014 |
| Z-0273-2015 | Peri Gyn Pack, Catalog number 900-1061. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. | 162 | Class I | Terminated | 10 Dec 2014 |
| Z-0274-2015 | Arthroscopy Pack, Catalog number 900-1062. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. | 256 | Class I | Terminated | 10 Dec 2014 |
| Z-0275-2015 | Peri Gyn Pack, Catalog number 900-1091. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. | 740 | Class I | Terminated | 10 Dec 2014 |
| Z-0276-2015 | Foley Catheter Kit, Catalog number 900-1127. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. | 9770 | Class I | Terminated | 10 Dec 2014 |
| Z-0277-2015 | Foley Catheter Kit, Catalog number 900-1139 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. | 1500 | Class I | Terminated | 10 Dec 2014 |
| Z-0278-2015 | Neuro Pack, Catalog number 900-1146. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. | 132 | Class I | Terminated | 10 Dec 2014 |
| Z-0279-2015 | Laparoscopy Pack, Catalog number 900-1176. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. | 156 | Class I | Terminated | 10 Dec 2014 |
| Z-0280-2015 | Laparoscopy OB GYN Pack, Catalog number 900-1192. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. | 105 | Class I | Terminated | 10 Dec 2014 |
| Z-0281-2015 | Open Heart Tray, Catalog number 900-1196C Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. | 71 | Class I | Terminated | 10 Dec 2014 |
| Z-0282-2015 | Laminectomy Pack, Catalog number 900-1202. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. | 180 | Class I | Terminated | 10 Dec 2014 |
| Z-0283-2015 | Premium Cesarean Pack, Catalog number 900-1294 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. | 150 | Class I | Terminated | 10 Dec 2014 |
| Z-0284-2015 | Premium Laparotomy Pack, Catalog number 900-1296. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. | 1020 | Class I | Terminated | 10 Dec 2014 |
| Z-0285-2015 | Premium OB Pack, Catalog number 900-1297. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. | 335 | Class I | Terminated | 10 Dec 2014 |
| Z-0286-2015 | Neuro Spine Pack, Catalog number 900-1300 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. | 207 | Class I | Terminated | 10 Dec 2014 |
| Z-0287-2015 | Pediatric Lap Pack, Catalog number 900-1383 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. | 56 | Class I | Terminated | 10 Dec 2014 |
| Z-0288-2015 | Open Heart Tray, Catalog number 900-1393. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. | 108 | Class I | Terminated | 10 Dec 2014 |
| Z-0289-2015 | Plastic Surgery Pack, Catalog number 900-1402. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. | 40 | Class I | Terminated | 10 Dec 2014 |
| Z-0290-2015 | Umbilical Vessel Catheter Kit, Catalog number 900-1408. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. | 48 | Class I | Terminated | 10 Dec 2014 |
| Z-0291-2015 | Cirugia Cardiovascular Case Cart, Catalog number 900-1415A. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. | 48 | Class I | Terminated | 10 Dec 2014 |
| Z-0292-2015 | Reyito Urological Pack, Catalog number 900-1460. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. | 315 | Class I | Terminated | 10 Dec 2014 |
| Z-0293-2015 | D&C Laparoscopy Pack, Catalog number 900-1476. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. | 108 | Class I | Terminated | 10 Dec 2014 |
| Z-0294-2015 | ENT Pack, Catalog number 900-1482. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. | 140 | Class I | Terminated | 10 Dec 2014 |
| Z-0295-2015 | Angiography Pack, Catalog number 900-1488. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. | 70 | Class I | Terminated | 10 Dec 2014 |
| Z-0296-2015 | Laparotomy Pack, Catalog number 900-149. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. | 892 | Class I | Terminated | 10 Dec 2014 |
The table shows 60 of 179 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 I: The highest of the three FDA recall classes.
The event in context
- Device events that started in 2014
- 1,176
- Share of these events in Class I
- 5%
- Product records in this event
- 179Median 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 |
| 10 Jul 2015 | ANGIODRAPE PK 4/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healin | Device | Class II | 170 |
| 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-0237-2015The 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 69448. https://recallregister.com/fda/i/69448/. 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:
US Distribution to Florida, New York and Puerto Rico..
- What quantity of product is in FDA event 69448?
- The event has 179 product records. The first record gives this quantity:
185000
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2014 have the same class?
- 5% of the 1,176 device events that started in 2014 are in Class I.