The Recall Desk
HighFDA (Devices)·Z-0165-2023·Announced 2022-11-09

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.

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 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
Hazard
  • seal-defect
  • 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 (2)

  • GTIN (01) 10195327027278
  • Lot Number 22OBK037

Distribution

Distributed nationwide across the United States.

Related recalls

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