Medline Surgical Convenience Kits Recalled for Weak Seal Compromise
Medline recalled 7,673 surgical convenience kits nationwide due to weak seals in the Pure Pouch component that may compromise sterility of surgical instruments. No injuries have been reported.
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 Class II recall involves a risk-of-harm medical device (surgical kit sterility compromise) where no injuries or illnesses have been reported. The weak seal poses a potential but unrealized risk of sterility breach.
Plain-English summary
Medline Industries has recalled 7,673 non-sterile surgical convenience kits due to weak seals in the Pure Pouch component. If the seal fails, the sterility of the surgical instruments contained in the kit could be compromised. The affected kits include multiple variants used for circulatory access, code carts, airway management, and wound care, distributed nationwide across 23 states.
The recall affects healthcare facilities in Alabama, California, Colorado, Connecticut, Florida, Illinois, Indiana, Maryland, Minnesota, Montana, North Carolina, New Jersey, Nevada, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin, and Wyoming. Each kit variant has specific lot numbers and expiration dates available from the FDA and manufacturer.
Healthcare facilities that have received these kits should discontinue use and contact Medline Industries for replacement. The FDA has classified this as a Class II recall. No infections or injuries related to this issue have been reported.
The recalled product
- Product
- Non-sterile convenience kits: a. Medline CC Drawer 4 IV Circulation, Pack #ACC010254B, containing a Pure Pouch component DYND04000, O.R. Scissors S/B, 5.5 Sterile. b. Medline Code Cart Drawer 2 Adult Kit, Pack ACC010365A, containing a Pure Pouch component DYNJ04048, Kelly
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- weak-seal
- sterility-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 (20)
- a. Pack #ACC010254B - Lot numbers 23KDB117
- exp. 11/3/2024
- and 23GDC173
- exp. 6/30/2024
- exp. 12/31/2024
- exp. 1/31/2024
- exp. 6/30/2025
- 23HDB243
- exp. 3/31/2024
- exp. 3/31/2025
- 23LDA035
- and 23HDC448
- 23HDC689
- and 23HDA419
- exp. 5/30/2024
- exp. 7/31/2025
- and 23HDB308
- 23KDC115
- exp. 2/28/2025
- 23IDB740
Distribution
Distributed nationwide across the United States.
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