American Contract Systems surgical kits recalled for sterilization defect
American Contract Systems Laparoscopy and Lap Chole surgical kits are being recalled because insufficient aeration time after sterilization may have compromised their sterility. The kits were distributed in seven U.S. states.
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 is a Class II FDA recall of sterilized surgical kits with potential sterility compromise. No illnesses or deaths have been reported. The kits represent a risk-of-harm product where injury has not yet been reported, placing this recall in the High category per the severity rubric.
Plain-English summary
American Contract Systems Laparoscopy Litho Std Pack convenience kit and American Contract Systems Lap Chole convenience kit are being recalled by the manufacturer American Contract Systems, Inc. These surgical instrument convenience kits are identified by Lot 981241 with an expiration date of 1/19/2025.
The kits were released with insufficient aeration time after sterilization, which may have compromised their sterility. The issue affects kits sterilized on the same cycle or in the same aeration chamber.
The affected kits were distributed nationwide to seven states: California, Kansas, Maine, Minnesota, Missouri, Nebraska, and South Dakota.
The recalled product
- Product
- American Contract Systems Laparoscopy Litho Std Pack convenience kit and American Contract Systems Lap Chole convenience kit
- Manufacturer
- American Contract Systems, Inc.
- Hazard
- Affected units
- 120
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 (3)
- UDI-DI 00191072190536
- Lot 981241
- Exp. Date 1/19/2025.
Distribution
Part of a larger recall action
This product is one of 8 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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