Hip Procedure Kit Recalled for Excessive Ethylene Oxide Sterilization Residuals
American Contract Systems Inc is recalling 393 units of the TPK Anterior Hip Pack nationwide due to ethylene oxide and ethylene chlorohydrin residuals exceeding safe limits for permanent exposure medical devices.
What this means for you
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 with a confirmed sterilization residue defect but no reported illnesses or injuries. This meets the rubric criterion for High severity as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
American Contract Systems Inc is recalling the TPK Anterior Hip Pack 176483-Procedure Kit (Catalog Number TPAH21E) due to excessive chemical residuals on the cast padding component. A total of 393 units were distributed nationwide.
Testing found that ethylene oxide and ethylene chlorohydrin residuals in the cast padding component exceeded the permitted limits for permanent exposure devices, as specified by the ANSI/AAMI/ISO 10993-7:(R)2012 standard. These residuals result from the device sterilization process.
Healthcare providers and surgical facilities using affected lot numbers 640231, 973241, 742231, and 934241 should stop using these kits. Contact American Contract Systems Inc for instructions on returning the recalled units or obtaining replacements.
The recalled product
- Product
- TPK ANTERIOR HIP PACK 176483-Procedure Kit Catalog Number: TPAH21E
- Manufacturer
- American Contract Systems Inc
- Hazard
- ethylene-oxide-residue
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: 00191072171726 LOT#"s: 640231 973241 742231 934241
Distribution
Distributed nationwide across the United States.
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