Medline Recalls Non-Sterile Cath Lab Kits Sold Without Sterilization Capability
Medline Industries is recalling 32 non-sterile cath lab kits because they were sold to accounts without the capability to sterilize them prior to use.
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: The recall involves a medical device where the intended sterilization process could not be performed by the recipient, creating a risk of harm from non-sterile use, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Medline Industries Inc is recalling 32 units of Kit Model #650600111, MTO Left Heart St Francis Hosp - PG. These products are NAMIC Cath Lab and Interventional Radiology (IR) Kits, which consist of combinations of devices from the NAMIC Fluid Management product families and other devices designed by original equipment manufacturers.
The recall was initiated because these non-sterile kits, which are intended to be sterilized prior to use, were sold to accounts that do not have the capabilities to perform sterilization. The affected products are identified by Lot 5551428 with an expiration date of 11/30/2022.
The products were distributed nationwide in the United States, including in the states of California, Colorado, Connecticut, Ohio, Texas, and New York. Users should stop using these kits and contact Medline Industries for further instructions.
The recalled product
- Product
- Kit Model #650600111, MTO Left Heart St Francis Hosp - PG - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consist of any combination of devices from the NAMIC Fluid Management finished good product families and potentially other devices designed and…
- Manufacturer
- Medline Industries Inc
- Category
- Medical Device — Cath Lab Kits
- Hazard
- Affected units
- 32
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)
- Lot 5551428
- Exp 11/30/2022
Distribution
Part of a larger recall action
This product is one of 8 recalled by Medline Industries Inc 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.
See all 8 products in this recall →Related recalls
Same manufacturer · Medline Industries Inc
See all →- HighMedline Chest Tube Kit Recalled for Non-Sterile Tape Component
FDA (Devices) · 2022-09-14
- ModerateMedline Hand Sanitizer Foam Recalled for Defective Containers
FDA (Drugs) · 2021-12-29
- ModerateBedside PICC CDS Convenience Kit Recalled for Expired Saline Component
FDA (Devices) · 2021-12-22
- HighMedline Venous Access Pack-LF Recalled for Expired Saline Component
FDA (Devices) · 2021-12-22
- HighEVLP Convenience Pack Recalled for Expired Injectable Component
FDA (Devices) · 2021-12-22
Same hazard · infection
See all →- SevereSafeguard US Operating LLC Recalls Compression Bandages Due to Degradation
FDA (Devices) · 2026-10-14
- SevereStryker Bard EP XT Decapolar Steerable Diagnostic EP Catheter Recalled for Sterile Barrier Breach
FDA (Devices) · 2026-10-14
- HighEmbosphere Microspheres Recalled Due to Packaging Sterility Concerns
FDA (Devices) · 2026-10-07
- SevereAurolab Trust Recalls FOCUS PI Eye Drops Due to Sterility Concerns
FDA (Drugs) · 2026-10-07
- HighFDA Recalls Performance Pro Nitrile Gloves Due to Defects
FDA (Devices) · 2026-10-07
Similar recalls
- HighMEDLINE namic Cardiovascular Kit Variants Recalled for Lack of Sterility
FDA (Devices) · 2024-05-22
- SevereMedline Surgical Kits Recalled for Potential Sterility Failure
FDA (Devices) · 2024-03-06
- SevereMedline Medical Kits and Trays Recalled for Potential Sterility Failure
FDA (Devices) · 2024-03-06
- HighMedline Recalls Bard MYPICC Kits Due to Potential Sterilization Failure
FDA (Devices) · 2018-07-18
- SevereMedline Surgical Kits Recalled for Potential Lack of Sterility
FDA (Devices) · 2024-03-06
- SevereMedline Recalls Sterile Sample Cath Lab Packs Due to Coating Defect
FDA (Devices) · 2014-03-05