Biopsy Drape Pack sterilization failure recall from American Contract Systems
American Contract Systems is recalling 224 Biopsy Drape Pack convenience kits due to insufficient aeration time during sterilization, which may have compromised the sterility of affected units. Lot 981241 distributed in CA, KS, ME, MN, MO, NE, and SD is 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: This is a Class II FDA recall of a medical device with potential for serious harm (infection from non-sterile equipment used in biopsies). No illnesses or injuries have been reported to date, placing it in the High category per the rubric criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
American Contract Systems, Inc. is recalling its Biopsy Drape Pack convenience kit. The recall affects 224 units distributed nationwide to healthcare facilities in California, Kansas, Maine, Minnesota, Missouri, Nebraska, and South Dakota. Lot number 981241 with expiration date January 19, 2025 is affected.
The kits were released with insufficient aeration time during sterilization. Proper aeration after sterilization is critical to ensure the sterility of medical devices. When aeration time is insufficient, the sterility of kits sterilized on the same cycle or in the same aeration chamber may be compromised.
Non-sterile surgical drape packs pose a risk of infection when used in medical procedures such as biopsies. Healthcare facilities that have received these kits should discontinue use and contact American Contract Systems, Inc. for instructions on product handling or replacement.
The recalled product
- Product
- American Contract Systems Biopsy Drape Pack convenience kit
- Manufacturer
- American Contract Systems, Inc.
- Affected units
- 224
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 00191072202246
- 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.
See all 8 products in this recall →Related recalls
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