Orthopedic knee procedure tray recalled for sterilization residue levels
American Contract Systems Inc is recalling 84 units of the ARTHRO KNEE BEACHES PACK BHS procedure tray because residual sterilization chemicals exceeded permissible exposure limits. The affected units were distributed nationwide.
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: FDA Class II medical device recall involving chemical residue that exceeded regulatory sterilization limits. No reported illnesses or injuries; the hazard is a risk-of-harm situation where permissible exposure levels were breached rather than documented patient harm.
Plain-English summary
American Contract Systems Inc is recalling 84 units of the ARTHRO KNEE BEACHES PACK BHS procedure tray (Catalog Number BPKB46B) due to excessive residual levels of ethylene oxide and ethylene chlorohydrin (EO/ECH) in the cast padding component.
The residual sterilization chemical levels exceeded the permissible exposure limits for permanent-use medical devices as specified in the ANSI/AAMI/ISO 10993-7/(R)2012 standard.
The recalled units were distributed nationwide. The affected lot numbers are 992241 and 914241. Healthcare facilities and professionals with these units should contact American Contract Systems Inc for recall instructions.
No illnesses or injuries have been reported to date in connection with this recall.
The recalled product
- Product
- ARTHRO KNEE BEACHES PACK BHS- Procedure tray Catalog Number: BPKB46B
- Manufacturer
- American Contract Systems Inc
- Affected units
- 84
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: 00191072197948 LOT#"s: 992241 914241
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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