Medline Industries, LP: Medline medical procedure convenience kits labeled as: 1) SMJ LAP CHOLE PACK-LF, Kit SKU DYNJ19974P; 2) DEPAUL ABDOMINAL ENDOSCOPY-LF, Kit SKU DYNJ20027K; 3) LAPAROSCOPY PACK-L

Hazard

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.

Details from the source

Reason for recall: 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. Distribution: US Nationwide distribution. Quantity: 456 units Lot/code info: Medline Kit SKU DYNJ19974P: UDI/DI 10198459138195 (EA) 40198459138196 (CS), Lot Number 25KMB830; Medline Kit SKU DYNJ19974P: UDI/DI 10198459138195 (EA) 40198459138196 (CS), Lot Number 25KMB831; Medline Kit SKU DYNJ20027K: UDI/DI 10198459228957 (EA) 40198459228958 (CS), Lot Number 25KMG395; Medline Kit SKU DYNJ20027K: UDI/DI 10198459228957 (EA) 40198459228958 (CS), Lot Number 25KMH132; Medline Kit SKU DYNJ20468J: UDI/DI 10195327024338 (EA) 40195327024339 (CS), Lot Number 25KMF540; Medline Kit SKU DYNJ25763N: UDI/DI 10198459138218 (EA) 40198459138219 (CS), Lot Number 25KMH134; Medline Kit SKU DYNJ25763O: UDI/DI 10198459603655 (EA) 40198459603656 (CS), Lot Number 25KMI209; Medline Kit SKU DYNJ32836B: UDI/DI 10195327037369 (EA) 40195327037360 (CS), Lot Number 25KBF167; Medline Kit SKU DYNJ43272K: UDI/DI 10198459257131 (EA) 40198459257132 (CS), Lot Number 25KME892; Medline Kit SKU DYNJ43976C: UDI/DI 10193489806694 (EA) 40193489806695 (CS), Lot Number 25KMG962; Medline Kit SKU DYNJ46939Q: UDI/DI 10198459404047 (EA) 40198459404048 (CS), Lot Number 25JDA437; Medline Kit SKU DYNJ46939Q: UDI/DI 10198459404047 (EA) 40198459404048 (CS), Lot Number 25LDA059; Medline Kit SKU DYNJ49688C: UDI/DI 10198459155017 (EA) 40198459155018 (CS), Lot Number 25KMG180; Medline Kit SKU DYNJ51347N: UDI/DI 10198459386428 (EA) 40198459386429 (CS), Lot Number 25JBW506; Medline Kit SKU DYNJ54081F: UDI/DI 10198459172410 (EA) 40198459172411 (CS), Lot Number 25KMB295; Medline Kit SKU DYNJ58864B: UDI/DI 1019845934

UPC codes

10198459138195, 40198459138196, 10198459228957, 40198459228958, 10195327024338, 40195327024339, 10198459138218, 40198459138219, 10198459603655, 40198459603656, 10195327037369, 40195327037360, 10198459257131, 40198459257132, 10193489806694, 40193489806695, 10198459404047, 40198459404048, 10198459155017, 40198459155018, 10198459386428, 40198459386429, 10198459172410, 40198459172411, 10198459346965, 40198459346966, 10195327248338, 40195327248339, 10198459228568, 40198459228569, 10193489273472, 40193489273473, 10198459076367, 40198459076368, 10198459031564, 40198459031565, 10198459328671, 40198459328672, 10198459383120, 40198459383121

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.