Medline Sterile Convenience Kits Recalled for Weak Breather Pouch Seals
Medline Industries is recalling sterile convenience kits for various medical procedures due to potential open or weak seals on breather pouches used in product packaging.
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 recall by FDA (a medical device used in sterile procedures). The hazard—compromised sterile packaging due to weak seals—presents a risk of contamination and potential patient harm in a high-risk medical setting, even though no reported illnesses are mentioned in the source text.
Plain-English summary
Medline Industries, LP is recalling 4,022 units of sterile convenience kits used for angiography, cardiac catheterization, interventional radiology, and other medical procedures. The kits are being recalled due to a potential for open or weak seals on purchased breather pouches used for packaging of the sterile items.
The affected kits include 20 different models distributed worldwide across the US, Canada, Mexico, Panama, and the Virgin Islands. Specific lot numbers and model numbers for each kit are identified in the FDA recall notice.
Customers who have purchased these kits should contact Medline Industries or consult the FDA recall notice for information on returning products or obtaining replacements. Healthcare facilities should verify whether they have received any of the affected lot numbers listed in the recall.
The recalled product
- Product
- Medline Convenience kits used for various procedures: 1) ANGIOGRAPHY DRAPE PACK, Model Number: HCP075G; 2) ENSEMBLE CORONAROGRAPHIE-LF, Model Number: DYNJ64354A; 3) RADIOL ANGIO PACK-LF, Model Number: 0M-CP01029D; 4) ARTERIOGRAM PACK 2, Model Number: DYNJ81454B; 5) CATH
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- weak-seal
- sterile-barrier-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 (20)
- 1) HCP075G
- UDI-DI: 10198459134456(each)
- 40198459134457(case)
- Lot Number: 24IBS428
- 2) DYNJ64354A
- UDI-DI: 10195327156312(each)
- 40195327156313(case)
- Lot Number: 24JBM450
- 3) 0M-CP01029D
- UDI-DI: 10888277858114(each)
- 40888277858115(case)
- Lot Number: 24JBM593
- 4) DYNJ81454B
- UDI-DI: 10198459100109(each)
- 40198459100100(case)
- Lot Number: 24JBN316
- 5) DYNJ51338C
- UDI-DI: 10193489241716(each)
- 40193489241717(case)
- Lot Number: 24JBN784
Distribution
Distributed nationwide across the United States.
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