Medline Arthroscopy Kit Recalled for Expired Irrigation Component
Medline Industries is recalling 286 Arthroscopy Kits (REF DYNJ904304B) containing an expired NaCl irrigation bag component. The affected kits were distributed to Minnesota, Nebraska, and Pennsylvania.
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 of a sterile medical device component with an expired expiration date. The expired irrigation bag is a risk-of-harm product; expired sterile components in surgical procedures affect product integrity and effectiveness. No illnesses or injuries have been reported. Per the rubric, risk-of-harm products without reported injury score at most 3 (High).
Plain-English summary
Medline Industries Inc. is recalling an Arthroscopy Kit convenience kit (REF DYNJ904304B) that contains an expired irrigation component. A total of 286 kits with lot number 19IBR389 are affected. The kits have an expiration date of September 30, 2020.
The recalled product includes an NaCl 3000mL Irrigation Bag component with an expiration date of August 1, 2020. Irrigation bags are sterile components used during surgical procedures. The product is identified by GTIN 10889942833290.
These kits were distributed to medical facilities in Minnesota, Nebraska, and Pennsylvania. Facilities that have received these kits should identify them by lot number 19IBR389.
Facilities should immediately discontinue use of these kits and contact Medline Industries Inc. for replacement or return instructions. Practitioners should verify the expiration dates of all components in their arthroscopy kits before use.
The recalled product
- Product
- Medline Arthroscopy Kit, convenience kit, REF DYNJ904304B, containing expired component NaCl 3000mL Irrigation Bag (exp. date 08/01/2020).
- Manufacturer
- Medline Industries Inc
- Hazard
- expired-component
- sterility-compromise
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)
- Lot 19IBR389
- Exp. 2020-09-30
- GTIN (01)10889942833290.
Distribution
Distributed nationwide across the United States.
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