Surgical Procedure Kits Recalled Due to Improper Sterilization
American Contract Systems is recalling 7,881 surgical procedure kits nationwide because components were sterilized without proper validation, risking loss of functionality or elevated chemical residue.
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: This FDA Class II recall involves surgical procedure kits where improperly sterilized components may lose functionality or contain elevated chemical residuals. With no reported illnesses or injuries but significant potential for patient harm during surgical use, this qualifies as High risk under the FDA rubric for risk-of-harm medical devices.
Plain-English summary
American Contract Systems, Inc. is recalling 7,881 surgical procedure kits and trays distributed nationwide. The recall affects 25 different kit types used for general and plastic surgery procedures, including brachytherapy packs, arthroscopy kits, laparotomy packs, and others.
During an internal investigation, ACS identified that certain components were added to ACS trays and then subjected to ACS's sterilization process. However, no documentation exists showing that these added components were assessed to determine whether they could safely tolerate the elevated temperatures and extended sterilization exposure used in the process.
As a result, the improperly validated components may lose functionality, lose drug efficacy if applicable, or may contain higher than specified levels of ethylene oxide residuals. These issues could compromise the safety and effectiveness of the surgical kits during use.
Healthcare facilities that received these kits should cease using them and contact American Contract Systems for guidance on replacement or disposal. Patients and providers with questions about specific lot numbers or kit models should consult the official FDA recall notice.
The recalled product
- Product
- 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…
- Manufacturer
- American Contract Systems, Inc.
- Affected units
- 7,881
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)
- a) AGBR90E
- UDI/DI 00191072036865
- Lot Numbers: 959231
- exp. 02/10/2024
- 681221
- exp. 11/15/2023
- 721221
- exp. 09/30/2023
- 771221
- exp. 08/147/2023
- 827221
- exp. 06/22/2023
- 897221
- exp. 04/13/2023
- b) AGMM60M
- UDI/DI 00191072063786
- Lot Numbers: 939231
- exp. 03/02/2024
- 638221
- exp. 4528812/28/2023
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 18 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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