Medline ST IUD Removal Hook Recalled Due to Weak Seals and Sterility Risk
Medline Industries is recalling 21,440 units of the ST IUD Removal Hook due to weak seals that may compromise sterility. The defect is undetectable to users and could increase infection risk.
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 risk of sterility breach leading to contamination and infection. No reported illnesses or injuries. This qualifies as 'High' (3) per the rubric as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Medline Industries, LP is recalling 21,440 units of the ST IUD Removal Hook 10" (Model 504090, Medline Item No. I68785) distributed nationwide in the United States. The recall is due to weak seals that may result in a breach of sterility. This defect is not detectable to users.
A breach of sterility can lead to increased risk of contamination and infection. Because the weakness is undetectable, users cannot identify affected devices before use.
Affected units are identified by Lot 2023021390 and UDI 10653160327141 (individual) or 00653160327144 (case). If you have devices from this lot, contact Medline Industries or your healthcare provider for instructions on device replacement and safe handling of affected units.
The recalled product
- Product
- ST IUD REMOVAL HOOK 10" (504090), Medline Item No. I68785
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- sterility-breach
- contamination
- infection
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 (2)
- UDI: 10653160327141 (ea) 00653160327144 (case)
- Lot 2023021390
Distribution
Distributed nationwide across the United States.
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