Laparoscopy and pelviscopy packs recalled over unconfirmed sterilization assurance requirements
American Contract Systems laparoscopy and pelviscopy procedure packs are recalled because the firm cannot confirm that product sterilization assurance requirements were met. 1,094 units are affected.
What this means for you
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 Laparoscopy Pack, model/item number EVLP61I, and Pelviscopy, model/item number EVPV29G, are being recalled. Affected kit lot numbers are listed in the recall notice, with UDI/DI 00191072194831 for the laparoscopy pack. The recall covers 1,094 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) LAPAROSCOPY PACK, MODEL/ITEM NUMBER EVLP61I; 2) PELVISCOPY, MODEL/ITEM NUMBER EVPV29G.
- Manufacturer
- American Contract Systems Inc
- Category
- Medical Device — Procedure Kits
- Affected units
- 1,094
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 (11)
- 1) MODEL/ITEM NUMBER EVLP61I: UDI/DI 00191072194831
- Kit Lot Numbers: 12-7359211
- 12-7077211
- 12-7115211
- 12-7162811
- 12-7224111
- 42-8276811
- 42-8200111
- 2) MODEL/ITEM NUMBER EVPV29G: UDI/DI 00191072194930
- Kit Lot Numbers: 12-7288711
- 12-7288711
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.
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