Pacemaker and venous access 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.
What this means for you
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 Pacer/Cath Lab Pack-LF under Medline kit SKU DYNJ0972604A, the Pacemaker/ICD Pack under SKU DYNJ33822L, the Venous Access Pack under SKU DYNJ45640B and the Pacemaker Set Up kit under SKU DYNJ63377D, among the kits listed in the enforcement record.
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
- Bandages and first aid kits: FIRST AID KIT 24/42PC, LUCKY FIRST AID BANDAGES 24CT
- Manufacturer
- GOLD STAR DISTRIBUTION INC
- Category
- Medical Device — Procedure kit
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 (4)
- FIRST AID KIT 24/42PC
- UPC 808829102536
- LUCKY FIRST AID BANDAGES 24CT
- UPC 808829041002. All codes purchased from this firm
Distribution
Part of a larger recall action
This product is one of 5 recalled by GOLD STAR DISTRIBUTION 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.
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