IUD Insertion Pack Tenaculum Devices Recalled Due to Unconfirmed Manufacturing Standards
Stradis Medical recalls IUD Insertion Packs because the firm cannot confirm tenaculum devices met required design and manufacturing standards. The recall affects 20 kits distributed nationwide.
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 device recall for manufacturing standards non-compliance. No illnesses or injuries reported and the specific hazard is theoretical. Per the rubric, Class II recalls without reported harm score at High (3).
Plain-English summary
Stradis Medical, LLC dba Stradis Healthcare is recalling IUD Insertion Packs containing tenaculum devices. The recall involves 20 kits identified by Part Number 618-034.
The firm is unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards. This manufacturing and quality control issue prompted the recall.
The affected packs were distributed across 31 U.S. states, the U.S. Virgin Islands, and Canada. No illnesses or injuries have been reported related to this recall.
The recalled product
- Product
- IUD Insertion Pack
- Manufacturer
- Stradis Medical, LLC dba Stradis Healthcare
- Hazard
- manufacturing-non-compliance
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)
- Part Number: 618-034
Distribution
Distributed nationwide across the United States.
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