Bandages and first aid kits recalled over rodent activity in storage
Gold Star Distribution is recalling first aid kits and bandages over potential exposure of rodents and rodent activity in its distribution center.
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: Scored 3 under the risk-of-harm criterion: the record cites rodent exposure and activity affecting product applied to wounds, and no injuries are reported.
Plain-English summary
Bandages and first aid kits, labeled as First Aid Kit 24/42pc and Lucky First Aid Bandages 24ct, distributed by Gold Star Distribution Inc, are being recalled.
The reason given in the enforcement record is potential exposure of rodents and rodent activity in the distribution center.
The record's quantity field reads 'unknown'. The recall covers UPC 808829102536 for the first aid kit and UPC 808829041002 for the bandages, and all codes purchased from the firm. The record gives distribution as US nationwide in the states of Minnesota. The FDA has classified the action as Class II.
Consumers who have this product should not use it and should follow the retailer's return instructions.
The recalled product
- Product
- Medline medical procedure convenience kits labeled as: 1) PACER / CATH LAB PACK-LF, Kit SKU DYNJ0972604A; 2) PACEMAKER/ICD PACK, Kit SKU DYNJ33822L; 3) VENOUS ACCESS PACK, Kit SKU DYNJ45640B; 4) PACEMAKER SET UP, Kit SKU DYNJ63377D; 5) PACK PACEMAKER CUSTOM,9909178…
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Wound care
- 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 (16)
- Medline Kit SKU DYNJ0972604A: UDI/DI 10889942403905 (EA) 40889942403906 (CS)
- Lot Number 25KMD144
- Medline Kit SKU DYNJ33822L: UDI/DI 10198459385582 (EA) 40198459385583 (CS)
- Lot Number 25KMD419
- Medline Kit SKU DYNJ45640B: UDI/DI 10193489494983 (EA) 40193489494984 (CS)
- Lot Number 25KMD793
- Medline Kit SKU DYNJ63377D: UDI/DI 10198459514579 (EA) 40198459514570 (CS)
- Lot Number 25KMI988
- Medline Kit SKU DYNJ65011D: UDI/DI 10198459017018 (EA) 40198459017019 (CS)
- Lot Number 25KMH161
- Medline Kit SKU DYNJ69143C: UDI/DI 10198459478505 (EA) 40198459478506 (CS)
- Lot Number 25LMB211
- Medline Kit SKU DYNJ69313: UDI/DI 10193489931822 (EA) 40193489931823 (CS)
- Lot Number 25KMJ489
- Medline Kit SKU DYNJ86007B: UDI/DI 10198459260452 (EA) 40198459260453 (CS)
- Lot Number 25KDB551.
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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