Medical Device Procedure Tray Recalled for Excessive Sterilant Chemical Residue
American Contract Systems Inc is recalling the BPKN15C Knee Basin Pack procedure tray because sterilant residues (ethylene oxide and ethylene chlorohydrin) exceed safe limits for permanent-use medical devices.
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: The recall involves a Class II FDA classification for a medical device with risk of harm from chemical residue exposure, but no reported illnesses or injuries have been documented. Per the rubric, this qualifies as a risk-of-harm product where injury has not yet been reported, resulting in a High severity rating.
Plain-English summary
American Contract Systems Inc is recalling the BPKN15C Knee Basin Pack BHS, a medical procedure tray. The recall was initiated because residual levels of ethylene oxide and ethylene chlorohydrin—sterilant chemicals used in the sterilization process—exceed the FDA-regulated limits for medical devices intended for permanent body exposure, as specified in the ANSI/AAMI/ISO 10993-7:2012 standard.
The affected product applies to 552 units distributed nationwide in the United States. The product is identified by UDI-DI 00191072200518 and the following lot numbers: 639231 and 928241.
This is classified as FDA Class II.
The recalled product
- Product
- BPKN15C KNEE BASIN PACK BHS- Procedure tray Catalog Number: BPKN15C
- Manufacturer
- American Contract Systems Inc
- Category
- Medical Device — Procedure Tray
- Hazard
- Affected units
- 552
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 (1)
- UDI-DI: 00191072200518 LOT#"s: 639231 928241
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 39 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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