[pending] Medline medical procedure convenience kits labeled as: 1) DRAWER 1 AIRWAY, Kit SKU ACC010270A;
Pending LLM rewrite. Source: FDA_DEVICE Z-1193-2026.
What this means for you
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: Pending LLM scoring against the rubric.
Plain-English summary
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 recalled product
- Product
- Medline medical procedure convenience kits labeled as: 1) DRAWER 1 AIRWAY, Kit SKU ACC010270A; 2) DRAWER 2, Kit SKU ACC010690; 3) DRAWER 3 SYR/DRS/MON/NG 1 OF 3, Kit SKU ACC011073; 4) HYPOSPADIUS PACK, Kit SKU DYNJ00282Q; 5) SJ NEURO PACK RFID-LF, Kit SKU DYNJ0101360K;
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Devices
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 (20)
- Medline Kit SKU ACC010270A: UDI/DI 10889942219827 (EA) 40889942219828 (CS)
- Lot Number 25LDA153
- Medline Kit SKU ACC010690: UDI/DI 10195327433307 (EA) 40195327433308 (CS)
- Lot Number 25LDA088
- Medline Kit SKU ACC011073: UDI/DI 10198459569333 (EA) 40198459569334 (CS)
- Lot Number 25LDA072
- Medline Kit SKU DYNJ00282Q: UDI/DI 10195327412029 (EA) 40195327412020 (CS)
- Lot Number 25KMC904
- Lot Number 25LMA071
- Medline Kit SKU DYNJ0101360K: UDI/DI 10195327662066 (EA) 40195327662067 (CS)
- Lot Number 25KMC709
- Medline Kit SKU DYNJ0220136S: UDI/DI 10198459566073 (EA) 40198459566074 (CS)
- Lot Number 25KMB403
- Lot Number 25JMF503
- Medline Kit SKU DYNJ0376635Q: UDI/DI 10198459422591 (EA) 40198459422592 (CS)
- Lot Number 25KMH121
- Lot Number 25KMF780
- Medline Kit SKU DYNJ0460768T: UDI/DI 10198459466809 (EA) 40198459466800 (CS)
- Lot Number 25KMH789
- Medline Kit SKU DYNJ0509186J: UDI/DI 10198459117626 (EA) 40198459117627 (CS)
Distribution
Distributed nationwide across the United States.
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