NICU PICC Insertion Bundle Recalled for Breather Pouch Seal Defects
Medline Industries recalls NICU PICC insertion bundles (50 kits) due to openings in breather pouch seals that compromise sterile barrier integrity. This Class II recall affects units distributed across the United States.
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 FDA Class II recall involves compromised sterile barriers on neonatal equipment. Per the rubric, it qualifies as a 'risk-of-harm product where injury has not yet been reported,' the criterion for High severity.
Plain-English summary
Medline Industries, LP is recalling CENTURION MEDICAL PRODUCTS NICU PICC Insertion Bundles (Reference CVI4470) used in neonatal intensive care procedures. The recall involves 50 kits bearing Lot Number 21KBB343, distributed nationwide in California, Minnesota, North Carolina, New York, Oklahoma, Pennsylvania, Tennessee, and Texas.
The breather pouches within these sterile surgical kits have been found to have openings in their seals. These pouches are designed to maintain sterile barrier integrity while allowing necessary gas exchange. Openings in the seal compromise the sterile field and create a contamination risk for vulnerable neonatal patients.
Healthcare facilities in the affected states that received these kits should verify their inventory against Lot Number 21KBB343 to identify potentially affected units.
The recalled product
- Product
- CENTURION MEDICAL PRODUCTS NICU PICC INSERTION BUNDLE W/O, REF CVI4470. Convenience kit used in medical procedures.
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- Affected units
- 50
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) 40653160316252
- Lot Number 21KBB343
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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