Medline Shoulder CDS Kits Recalled Due to Expired Irrigation Component
Medline Industries is recalling 286 Shoulder CDS convenience kits that may contain an expired NaCl irrigation component. Users should stop using the kits and contact the manufacturer for return instructions.
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 expired irrigation component in the medical device kit represents a risk-of-harm situation where injury has not yet been reported, fitting the rubric criterion for High severity.
Plain-English summary
Medline Industries Inc is recalling 286 Shoulder CDS convenience kits that may contain an expired irrigation component. The affected kits are reference number REF DYNJ902837D (Lot 19IBE968, expiration date 09/30/2020) and REF DYNJ902837F (Lot 20LBU450, expiration date 07/31/2021). The kits contain NaCl 3000mL irrigation solution components with an expiration date of August 1, 2020.
The affected kits were distributed in Minnesota, Nebraska, and Pennsylvania.
Consumers and healthcare facilities with these kits should stop using them immediately. Contact Medline Industries Inc for instructions on return or disposal of the recalled products.
The recalled product
- Product
- Medline Shoulder CDS convenience kits, REF DYNJ902837D and REF DYNJ902837F, containing expired component NaCl 3000mL Irrigation Bag (exp. date 08/01/2020).
- Manufacturer
- Medline Industries Inc
- Category
- Medical Device — Surgical Kit
- Hazard
- expired-irrigation-solution
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 (6)
- REF DYNJ902837D - Lot 19IBE968
- exp. 2020-09-30
- GTIN (01)10193489720549
- and REF DYNJ902837F - Lot 20LBU450
- Exp. 2021-07-31
- GTIN (01)10193489357233.
Distribution
Distributed nationwide across the United States.
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