Medline medical procedure kits recalled due to potential non-sterile product risk
Medline is recalling four types of medical procedure convenience kits that may contain non-sterile products if the pouch seal is opened. Approximately 197 units were distributed nationwide and internationally.
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 recall with no reported illnesses or injuries. The hazard is theoretical—potential non-sterile product if the pouch seal is breached—meeting the criterion for 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Medline Industries is recalling certain medical procedure convenience kits due to the potential for non-sterile products. The recall involves four product types: Lithotomy Pack (REF DYNJ24362C), Major Gyne Laparoscopy (REF DYNJ46774B), Gyn Ancilary Pack (REF DYNJ84509), and Gyn Lithotomy Minor (REF DYNJ907707). These kits were packaged in breather pouches with lot number 323080002.
The kits may contain non-sterile products if the vendor seal of the pouch is opened or unsealed. This condition could result in the use of non-sterile products during medical procedures.
Approximately 197 units were distributed worldwide, including the United States, Canada, and Panama. Healthcare providers should check their inventory using the reference numbers and lot number provided to identify affected products.
Use of non-sterile medical products in medical procedures poses a potential health risk. Affected kits should not be used, and healthcare providers should contact Medline Industries for guidance on replacement or return of affected products.
The recalled product
- Product
- Medline brand medical procedure convenience kits, labeled as: a) LITHOTOMY PACK, REF DYNJ24362C; b) MAJOR GYNE LAPAROSCOPY SHSC, REF DYNJ46774B; c) GYN ANCILARY PACK, REF DYNJ84509; d) GYN LITHOTOMY MINOR, REF DYNJ907707
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- non-sterile-product
- seal-breach
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 (16)
- a) REF DYNJ24362C
- UDI/DI 40889942830054 (each)
- 10889942830053 (case)
- Lot Numbers: 24ABG207
- b) REF DYNJ46774B
- UDI/DI 40889942582748 (each)
- 10889942582747 (case)
- Lot Numbers: 23LBN531
- c) REF DYNJ84509
- UDI/DI 40195327372881 (each)
- 10195327372880 (case)
- Lot Numbers: 23LBL712
- d) REF DYNJ907707
- UDI/DI 40193489848978 (each)
- 10193489848977 (case)
- Lot Numbers: 24ABR224
Distribution
Distributed nationwide across the United States.
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