Medline Radiology Procedure Pack Breather Pouches Recalled for Seal Defects
Medline is recalling 240 Radiology Procedure Packs because some breather pouches show seal openings that could compromise sterility. The affected kits were distributed nationwide.
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 a Class II medical device recall with no reported illnesses or injuries. The compromised sterility seals present a risk of contamination, but no actual harm has been reported. Per the rubric, risk-of-harm products without reported injury qualify as High severity.
Plain-English summary
Medline Industries, LP is recalling 240 MEDLINE RADIOLOGY PROCEDURE PACK units (REF DYNJ67150A) used in medical procedures. The affected lot number is 22OBK037.
Some breather pouches in these sterile surgical kits show openings in the seal. These seal defects could compromise the sterility of the kit contents and allow contamination during medical procedures.
The affected kits were distributed nationwide to healthcare facilities in California, Minnesota, North Carolina, New York, Oklahoma, Pennsylvania, Tennessee, and Texas.
The recalled product
- Product
- MEDLINE RADIOLOGY PROCEDURE PACK, REF DYNJ67150A. Convenience kit used in medical procedures.
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Surgical Kit
- Affected units
- 240
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 (2)
- GTIN (01) 10195327027278
- Lot Number 22OBK037
Distribution
Part of a larger recall action
This product is one of 13 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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