Device recall: Custom procedural convenience kits and trays, anesthesia, labeled as: a) HEART ANESTHESIA BUNDLE NS, Kit Number…
Class II FDA enforcement event 93656. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and subjected to the ACS sterilization process. There is no supporting documentation stating the "piggybacked" components were assessed to determine if they were suitable for exposure to elevated temperatures for an extended period of time and further exposure to sterilization. As a result,…
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
American Contract Systems, Inc. started this device recall on 29 Nov 2023. The firm address in the FDA record is in Temple Terrace, FL. FDA put the recall in Class II. FDA event 93656 has 18 product records. The first FDA enforcement report date is 7 Feb 2024. The record gives the status Ongoing.
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 Nationwide distribution.
Recalling firm
American Contract Systems, Inc., Temple Terrace, FL.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
18 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0816-2024 | Custom procedural convenience kits and trays, anesthesia, labeled as: a) HEART ANESTHESIA BUNDLE NS, Kit Number LMHA01V; b) OR/Anesthesia Central Line Insertion Kit, Kit Number UIAN43L | 182 units | Class II | Ongoing | 7 Feb 2024 |
| Z-0817-2024 | Custom procedural convenience kits and trays, cardiac, labeled as: a) HEART CATHETERIZATION TRAY, kit number JRHC45G; b) TAVR PACK, kit number LLTV10; c) CATH PED LF SJH, kit number SJCA21F; d) CATH HEART ADL LF SJH, kit number SJCH22F; e) INT RAD PORTS-LF - 206060, kit number UDIR58AL | 4394 units | Class II | Ongoing | 7 Feb 2024 |
| Z-0818-2024 | Procedural convenience kits and trays, cardiac, labeled as: a) EP LAB BI V IMPLANT PACK, kit number AGBI64J; b) LAB DEVICE IMPLANT, kit number AGDI40J; c) LAB DEVICE IMPLANT, kit number AGDI40K; d) MINOR VASCULAR, kit number AGMV26O; e) OPEN HEART ACCESSORY, kit number AGOH98Q; f) OPEN HEART ACCESSORY, kit number… | 12291 units | Class II | Ongoing | 7 Feb 2024 |
| Z-0819-2024 | Custom procedural convenience kits and trays, cardiac, labeled as: a) CENTRAL LINE INSERTION PACK, kit number LLCE52; b) Adult Central Line Insertion Supply Kit, kit number UICL44N; c) Pediatric Central Line Insertion, kit number UIPL77K | 290 units | Class II | Ongoing | 7 Feb 2024 |
| Z-0820-2024 | Custom procedural convenience kits and trays, ear, nose & throat, labeled as: a) T AND A PACK AGH ASC, kit number AGTA48J; b) OPSC EAR PACK, kit number LLEO66; c) T AND A PACK, kit number MMTA41F | 804 units | Class II | Ongoing | 7 Feb 2024 |
| Z-0821-2024 | Custom procedural convenience kits and trays, gastroenterological & urological, labeled as: AHN BIOPSY STERILE, kit number AHBP12A | 95 units | Class II | Ongoing | 7 Feb 2024 |
| Z-0822-2024 | Custom procedural convenience kits and trays, gastroenterological & urological, labeled as: a) LAP KIDNEY MODULE, kit number AGKD50L; b) ROBOTIC PROSTATE PACK - 264852, kit number ANPR34S; c) LAP CHOLE - 213388, kit number BFLC02AD; d) GENERAL LAPAROSCOPY PACK, kit number GUGE09I; e) LAP CHOLE PACK, kit number… | 3196 units | Class II | Ongoing | 7 Feb 2024 |
| Z-0823-2024 | Custom procedural convenience kits and trays, urological, labeled as: a) UROLOGY DAVINCI PACK, kit number HGUR87G; b) CYSTO PACK, kit number LVCY20; c) URO ROBOTIC PACK, kit number LVUR44; | 1031 units | Class II | Ongoing | 7 Feb 2024 |
| Z-0824-2024 | Custom procedural convenience kits and trays, general & plastic surgery, labeled as: a) Breast Plastics Pack, kit number BBPL20D; b) MINOR PLASTIC, kit number WPMP16H | 112 units | Class II | Ongoing | 7 Feb 2024 |
| Z-0825-2024 | Custom procedural convenience kits and trays, general & plastic surgery, labeled as: a) BRACHY THERAPY PROCEDURE PAC, kit number AGBR90E; b) BRACHY THERAPY PROCEDURE PAC, kit number AGBR90E; c) MINI MINOR AGH ASC PACK, kit number AGMM60M; d) OUTPATIENT PORT ACCESS KIT 307907, kit number AHPO55J; e) General Pack, kit… | 7881 units | Class II | Ongoing | 7 Feb 2024 |
| Z-0826-2024 | Custom procedural convenience kits and trays, general hospital use, labeled as: a) Baby PICC Kit, kit number UIBP90J; b) Baby PICC Kit, kit number UIBP90K; c) PORT PACK (PS 058330), kit number UIPO82AB; d) Pediatric PICC Kit, kit number UIPP76K; | 244 units | Class II | Ongoing | 7 Feb 2024 |
| Z-0827-2024 | Custom procedural convenience kits and trays, general hospital use, labeled as: a) IR NEURO PACK, kit number AGNE20J; b) ADULT CRANIOTOMY PACK, kit number LLCR99; c) LAMINECTOMY PACK, kit number LLLC26; d) KIT, CRANIOTOMY, kit number MMCR11J; e) KIT, NEURO SPINE, kit number MMNS20H; f) IR NEURO PACK, kit number… | 2717 units | Class II | Ongoing | 7 Feb 2024 |
| Z-0828-2024 | Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled as: a) LOWER PELVIC PACK, kit number AGLP52L; b) OB/GYN DAVINCI PACK A RG BASIN, kit number HGOB98G; c) DAVINCI GYN PACK, kit number HHDV17; d) KIT, GYNE ROBOTIC, kit number MMGR44D; e) KIT, MAJOR LITHOTOMY, kit number MMJL16E; f)… | 1020 units | Class II | Ongoing | 7 Feb 2024 |
| Z-0829-2024 | Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled as: a) LABOR & DELIVERY PACK, kit number HILD52F; b) LABOR & DELIVERY PACK, kit number HILD52G | 114 units | Class II | Ongoing | 7 Feb 2024 |
| Z-0830-2024 | Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled as: a) C-SECTION PACK, kit number FDCS01AA; b) C-SECTION PACK, kit number FDCS01AB; c) C-SECTION STERILE PACK, kit number HGCS68J; d) C-SECTION PACK, kit number HICS50H; e) C-SECTION PPS, kit number LLCI66; f) C-Section drape Pack,… | 1818 units | Class II | Ongoing | 7 Feb 2024 |
| Z-0831-2024 | Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled as: a) LavH, kit number BBLV21C; b) LAP HYST 247540, kit number BFHY75U | 144 units | Class II | Ongoing | 7 Feb 2024 |
| Z-0832-2024 | Custom procedural convenience kits and trays, Ophthalmic use, labeled as: a) EYE PACK, kit number LVEY27; b) Laminectomy, kit number UIOL34AG | 940 units | Class II | Ongoing | 7 Feb 2024 |
| Z-0833-2024 | Custom procedural convenience kits and trays, Othopedic use, labeled as: a) HIP FRACTURE, kit number AHHF15C; b) HIP FRACTURE, kit number AHHF15D; c) Hand Pack, kit number BBHP10E; d) Lower Extremity, kit number BBLE40B; e) Custom Podiatry, kit number BOCP70J; f) ROBOTIC PACK, kit number BPAR65A; g) HIP PINNING PACK,… | 5524 units | Class II | Ongoing | 7 Feb 2024 |
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 2023
- 917
- Share of these events in Class II
- 88%
- Product records in this event
- 18Median of the firm: 4
- Events of the firm on the register
- 22
Other events of the firm
Official channels
- FDA enforcement report Z-0816-2024The 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 93656. https://recallregister.com/fda/ii/93656/. 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 Nationwide distribution.
- What quantity of product is in FDA event 93656?
- The event has 18 product records. The first record gives this quantity:
182 units
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2023 have the same class?
- 88% of the 917 device events that started in 2023 are in Class II.