Neonatal PICC Surgical Kits Recalled for Non-Sterile External Packaging
Medline Industries is recalling CENTURION MEDICAL PRODUCTS neonatal PICC surgical kits because the perforated bag fails to maintain sterility on the exterior packaging. Only contents inside are sterile.
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: FDA Class II medical device with a design defect that compromises sterility assurance on external packaging of neonatal surgical kits. No illnesses or injuries have been reported, but the risk of contamination and infection is significant given the high-risk neonatal population.
Plain-English summary
Medline Industries, LP is recalling 60 units of CENTURION MEDICAL PRODUCTS NEONATAL PICC TRAY (Reorder Number CVI4685, Lot # 22BBJ259) distributed nationwide.
The surgical convenience kits contain a perforated bag design that prevents the exterior wrapping from remaining sterile. The design flaw means only the contents inside the kit wrapping maintain sterility, while the outside of the kit is not sterile.
Neonatal patients and healthcare facilities using these kits may be affected by the non-sterile external packaging.
Healthcare facilities should cease use of affected lots and contact Medline Industries for replacement or further instructions.
The recalled product
- Product
- Surgical convenience kits labeled as: CENTURION MEDICAL PRODUCTS NEONATAL PICC TRAY, Reorder Number CVI4685
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 60
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 40653160990384
- Lot # 22BBJ259
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 20 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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