Maxillofacial and plastics packs recalled over cracking MASTISOL adhesive tubing
Medline is recalling 66 units 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 MEM Maxillofacial Pack-LF under Medline kit SKU DYNJ0660040R, Plastics VCH under SKU DYNJ39225K, the WT Breast Pack under SKU DYNJ46620I, the Endo/Aug Pack under SKU DYNJ59250I and the KMC Plastic/G kit, 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 66 units, 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) MEM MAXILLOFACIAL PACK-LF, Kit SKU DYNJ0660040R; 2) PLASTICS VCH, Kit SKU DYNJ39225K; 3) WT BREAST PACK, Kit SKU DYNJ46620I; 4) ENDO / AUG PACK, Kit SKU DYNJ59250I; 5) KMC PLASTIC/GEN PACK-LF, Kit SKU…
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Procedure kit
- Affected units
- 66
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 (17)
- Medline Kit SKU DYNJ0660040R: UDI/DI 10889942220083 (EA) 40889942220084 (CS)
- Lot Number 25KMG652
- Medline Kit SKU DYNJ39225K: UDI/DI 10198459102257 (EA) 40198459102258 (CS)
- Lot Number 25JMJ958
- Lot Number 25KMJ566
- Medline Kit SKU DYNJ46620I: UDI/DI 10198459404009 (EA) 40198459404000 (CS)
- Lot Number 25KBE927
- Medline Kit SKU DYNJ59250I: UDI/DI 10198459359941 (EA) 40198459359942 (CS)
- Lot Number 25KMB767
- Medline Kit SKU DYNJ65980J: UDI/DI 10198459423727 (EA) 40198459423728 (CS)
- Lot Number 25KMJ630
- Medline Kit SKU DYNJ68288A: UDI/DI 10195327056995 (EA) 40195327056996 (CS)
- Lot Number 25KMF183
- Medline Kit SKU MNS13035: UDI/DI 10653160990482 (EA) 40653160990483 (CS)
- Lot Number 25KME754
- Medline Kit SKU PHS41746D: UDI/DI 10198459438820 (EA) 40198459438821 (CS)
- Lot Number 25KMD226.
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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