Perfusion and laparoscopy packs recalled over unjustified sterilization of certain components
American Contract Systems supplement, kidney perfusion and lapchol/appy packs are recalled because the firm cannot confirm that product sterilization assurance requirements were met. 6,617 units are affected.
The agency’s classification
FDA (Devices): Class II
Class II is 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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Rubric level 3 covers risk-of-harm products where injury has not yet been reported; unconfirmed sterility on a surgical procedure pack is a potential harm and no injuries are reported.
Plain-English summary
American Contract Systems medical procedure kits and trays labelled as A-C Supplement Pack (205946), model/item number ANCV67X; Kidney Perfusion Pack (208439), model/item number ANKP15AD; and LapChol/Appy Pack, model/item number FYLA38G, are being recalled. Affected kit lot numbers are listed in the recall notice, with UDI/DI 00191072203021 for the supplement pack. The recall covers 6,617 units distributed in Illinois and Louisiana.
During an internal investigation, American Contract Systems determined that the rationale for sterilization of certain components was not justified and that some components are not fit for further sterilization according to its procedures. As a result, the firm is unable to confirm that product sterilization assurance requirements were met. The FDA classified the action as Class II.
Hospitals and surgical centres holding these lot numbers should quarantine affected stock and follow the manufacturer's instructions for return or replacement.
The recalled product
- Product
- AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) A-C SUPPLEMENT PACK - 205946, Model/Item Number ANCV67X; 2) KIDNEY PERFUSION PACK - 208439, Model/Item Number ANKP15AD; 3) LAPCHOLAPPY PACK, Model/Item Number FYLA38G; 4) CYSTO PACK, Model/Item…
- Manufacturer
- American Contract Systems Inc
- Category
- Medical Device — Procedure Kits
- Affected units
- 6,617
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 1) Model/Item Number ANCV67X: UDI/DI 00191072203021
- Kit Lot Numbers: 42-7789611
- 42-8074911
- 42-7925811
- 42-8005111
- 2) Model/Item Number ANKP15AD: UDI/DI 00191072235176
- Kit Lot Numbers: 42-7916611
- 42-8047711
- 3) Model/Item Number FYLA38G: UDI/DI 00191072003706
- Kit Lot Numbers: 42-7905711
- 42-8134111
- 4) Model/Item Number HSCY13M: UDI/DI 00191072005571
- Kit Lot Numbers: 42-8125311
- 42-7959411
- 5) Model/Item Number HSDR10K: UDI/DI 00191072005588
- Kit Lot Numbers: 42-7984111
- 42-7883711
- 6) Model/Item Number HSMD20H: UDI/DI 00191072237262
- Kit Lot Numbers: 42-7937911
- 7) Model/Item Number PDSA12D: UDI/DI 00191072137111
Distribution
Part of a larger recall action
This product is one of 9 recalled by American Contract Systems Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 9 products in this recall →Related recalls
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