Pediatric Urology Equipment Recalled Due to Improper Sterilization
American Contract Systems is recalling Pediatric Urology Wolson Packs due to components being exposed to unapproved sterilization processes. Components may have lost functionality or reduced efficacy, potentially compromising device performance.
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: This is an FDA Class II medical device recall without reported illnesses or injuries. The hazard involves potential loss of component functionality and reduced drug efficacy in pediatric medical equipment, representing a risk-of-harm situation where no confirmed injuries have been reported yet.
Plain-English summary
American Contract Systems, Inc. is recalling Pediatric Urology Wolson Packs (model REF BPPU55A) comprising 448 cases distributed nationwide. Affected lot numbers are 923231 and 977231.
An internal investigation identified that two components—an I.V. Catheter (part 4252535-02) and Adhesive Dermabond (part DHVM12)—were inadvertently exposed to the sterilization process using ethylene oxide gas at temperatures higher than approved by the component manufacturers. This exposure may have compromised component integrity.
The affected components may lack functionality, have reduced drug efficacy, or contain ethylene oxide residuals exceeding specified levels. These defects could prevent the urology devices from functioning as intended during clinical use.
No illnesses or injuries have been reported. Healthcare providers and patients with affected units should discontinue use and contact American Contract Systems for further guidance.
The recalled product
- Product
- Pediatric Urology Wolson Pack, REF BPPU55A
- Manufacturer
- American Contract Systems, Inc.
- Hazard
- loss-of-function
- reduced-efficacy
- sterilization-defect
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 00191072187949
- Lot Numbers: 923231
- 977231
Distribution
Distributed nationwide across the United States.
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