MEDLINE namic Cardiovascular Kit Variants Recalled for Lack of Sterility
Medline Industries recalls multiple namic CONVENIENCE KIT variants used in cardiovascular procedures due to lack of sterility assurance. Approximately 570 units distributed nationwide may pose infection risk.
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 device with a sterility assurance failure affecting invasive cardiovascular procedures, representing a significant risk of patient harm through infection. No illnesses or injuries have been reported in the source text, placing this at the level of a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Medline Industries, LP is recalling multiple variants of its namic CONVENIENCE KIT, a collection of manifold and tubing kits used in cardiovascular procedures including carotid, left heart, right heart, and valve imaging interventions. The affected kits include 16 separate product variants with reference numbers ranging from 60011045 to 600705710, with a total of 570 units distributed.
The FDA Class II recall was initiated because the kits have a lack of sterility assurance. Sterile medical devices used in invasive cardiovascular procedures require validated sterilization to prevent patient infection.
The recalled kits were distributed nationwide across Alabama, Florida, Kentucky, Mississippi, Texas, Washington, Wisconsin, North Carolina, Virginia, California, South Dakota, Tennessee, Georgia, and Pennsylvania. Healthcare facilities and clinicians who received these kits should stop using them immediately and contact Medline Industries or the FDA for replacement instructions.
The recalled product
- Product
- namic CONVENIENCE KIT, a) CAROTID MANIFOLD KIT, REF 60011045; b) 3V MANIFOLD KIT ON WITH NAMIC DT & WASTE MANAGEMENT, REF 60070582; c) LEFT HEART KIT, REF 60071822; d) LEFT HEART KIT, REF 60080085; e) CONVENIENCE KIT, REF 60100055; f) CONVENIENCE KIT, REF 60101041…
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 570
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 (10)
- a) UDI/DI 10193489040456
- Lot Numbers: 0000113192
- b) UDI/DI 10193489044195
- Lot Numbers: 0000113331
- c) UDI/DI 10193489044386
- Lot Numbers: 0000112999
- d) UDI/DI 10193489044416
- Lot Numbers: 0000113000
- d) UDI/DI 10193489044935
- Lot Numbers: 0000113187
Distribution
Part of a larger recall action
This product is one of 2 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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