Medline Tubal Ligation Kits Recalled for Potential Sterility Compromise
Medline is recalling certain tubal ligation procedure kits due to potential loss of sterility if the pouch seal becomes compromised during storage or handling.
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 a risk-of-harm product (surgical instruments for use in procedures) where sterility compromise could lead to serious infection, but no illnesses or injuries have been reported. The hazard is conditional on seal compromise and theoretical. Per the rubric, Class II recalls without reported harm and with theoretical hazards have a maximum score of 3.
Plain-English summary
Medline Industries is recalling certain Tubal Ligation Pack kits (REF DYNJ66230B) that were packaged in breather pouches with lot number 323080002. These kits may contain non-sterile product if the vendor seal of the pouch is opened or unsealed.
The recalled kits were distributed worldwide, including throughout the United States, Canada, and Panama. Approximately 22 units were affected.
Healthcare providers and consumers should not use kits if the pouch seal appears compromised or open. Contact Medline Industries for product replacement or further information.
The recalled product
- Product
- Medline TUBAL LIGATION PACK, REF DYNJ66230B; medical procedure convenience kit
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- non-sterile-product
- infection-risk
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 40195327206087 (each)
- 10195327206086 (case)
- Lot Numbers: 24ABG688
Distribution
Distributed nationwide across the United States.
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