Cath lab and loop recovery packs recalled over cracking adhesive tubing
Medline is recalling 1,928 total of procedure convenience kits containing MASTISOL liquid adhesive, which was recalled after complaints that the butyrate tubing cracked during actuation.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Scored 2 because the record cites a supplier component recall over cracking tubing with no stated consequence or reported harm.
Plain-English summary
Medline medical procedure convenience kits are being recalled by Medline Industries, LP, covering the Cath Lab Pacemaker Pack-LF under Medline kit SKU DYNJ64837C and the Loop Recovery Pack under SKU DYNJT7034.
The record states the Medline kits were manufactured and distributed containing MASTISOL liquid adhesive, which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.
The record lists 1,928 total, with kit SKUs, UDI/DI codes and lot numbers recorded in the enforcement record. Distribution was nationwide in the United States. The FDA has classified the action as Class II.
The record describes a component recalled at the supplier and states no further consequence or reported injuries. Facilities should quarantine affected kits and follow Medline's instructions.
The recalled product
- Product
- Medline medical procedure convenience kits labeled as: 1) CATH LAB PACEMAKER PACK-LF, Kit SKU DYNJ64837C; 2) LOOP RECOVERY PACK, Kit SKU DYNJT7034;
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Procedure kit
- Affected units
- 1,928
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 (5)
- Medline Kit SKU DYNJ64837C: UDI/DI 10198459139482 (EA) 40198459139483 (CS)
- Lot Number 25KMJ193
- Medline Kit SKU DYNJT7034: UDI/DI 10198459592591 (EA) 40198459592592 (CS)
- Lot Number 25KMI766
- .
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 15 recalled by Medline Industries, LP 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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