Medline sterile convenience kits recalled for weak breather pouch seals
Medline is recalling two models of sterile convenience kits (PAIN PACK and PAIN TRIAL PACK) due to potential open or weak seals on breather pouches used in the packaging.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 an FDA Class II recall involving sterile medical device kits with potential packaging integrity issues. The weak or open seals on breather pouches could compromise the sterility of the contents, creating a risk of harm to patients using these sterile kits. No illnesses or injuries are reported in the source text.
Plain-English summary
Medline Industries, LP is recalling Medline Convenience kits used for various procedures: the PAIN PACK (Model Number DYNJ67577A) and PAIN TRIAL PACK (Model Number DYNJ67576A). The recall is due to a potential for open or weak seals on purchased breather pouches used for packaging these sterile convenience kits.
The affected products have been distributed worldwide, including US Nationwide and the countries of Canada, Mexico, Panama, and the Virgin Islands. Specific lot numbers affected are: Lot Number 24JBX252 for the PAIN PACK and Lot Number 24JBX286 for the PAIN TRIAL PACK.
Consumers who have purchased these kits should stop using them and contact Medline Industries, LP for further instructions.
The recalled product
- Product
- Medline Convenience kits used for various procedures: 1) PAIN PACK, Model Number: DYNJ67577A; 2) PAIN TRIAL PACK, Model Number: DYNJ67576A;
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 40
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 (8)
- 1) DYNJ67577A
- UDI-DI: 10193489980349(each)
- 40193489980340(case)
- Lot Number: 24JBX252
- 2) DYNJ67576A
- UDI-DI: 10193489980455(each)
- 40193489980456(case)
- Lot Number: 24JBX286
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 34 recalled by MEDLINE INDUSTRIES, LP - Northfield under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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