Recall Z-2695-2024

MEDLINE INDUSTRIES, LP - Northfield · initiated March 22, 2024

Class II Open, Classified

Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature

Product

LINER, SOFT, SUCTION CANISTER, 1500CC, REF OR929K

Codes / lots: UDI/DI 40888277276209 (package), 10888277276208 (unit), Lot Numbers: 670220928, 670220928, 670221020, 670221010, 670221121, 670220928, 670221128, 670221128, 670221128, 670230317, 670230419, 670230419, 670230317, 670230419

Reason for recall

A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.

FDA-determined cause: Under Investigation by firm

Action taken

Medline Industries issued a Safety Alert to its consignees on 03/22/2024 via email and certified mail. The notice explained the problem with the device and requested that consignees follow the instructions for use. Distributors or those who further transferred the affected product were directed to notify their consignees.

Details

Recall number
Z-2695-2024
Initiated
March 22, 2024
Posted by FDA
August 22, 2024
Product code
KDQ – Bottle, Collection, Vacuum
Distribution
Worldwide - US Nationwide and the countries of Panama, Mexico, Canada, Qatar, El Salvador, Oman, Colombia, Singapore.
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-2694-2024 Class IILINER, SOFT, SUCTION CANISTER, 1500CC, REF DYNDSCL1500A slight dimensional variation which has the potential for increased difficulty fitting into outer canister. 03/22/2024Open, Classified
Z-2696-2024 Class II1500ML SOFT LINER, 1/4X6 TBG NS, REF OR926KA slight dimensional variation which has the potential for increased difficulty fitting into outer canister. 03/22/2024Open, Classified
Z-2697-2024 Class II1,5L MED-SOFT LINER W/ 6MMX1,8M TUB. & ADULT VC, REF OR53926A slight dimensional variation which has the potential for increased difficulty fitting into outer canister. 03/22/2024Open, Classified
Z-2698-2024 Class II1,5L MED-SOFT LINER W/ 6MMX3M TUB. & ADULT VC, REF OR53929A slight dimensional variation which has the potential for increased difficulty fitting into outer canister. 03/22/2024Open, Classified
Z-2699-2024 Class II1,5L MED-SOFT SINGLE LINER WITH SOLIDIFIER, REF OR1920PGA slight dimensional variation which has the potential for increased difficulty fitting into outer canister. 03/22/2024Open, Classified
Z-2700-2024 Class IIMedline medical procedure kits labeled as follows: a) ANESTHESIA CIRCUIT ADULT, REF…A slight dimensional variation which has the potential for increased difficulty fitting into outer canister. 03/22/2024Open, Classified
Z-2701-2024 Class IIMedline medical procedure kits labeled as follows: a) HEART ANESTHESIA SET UP, REF…A slight dimensional variation which has the potential for increased difficulty fitting into outer canister. 03/22/2024Open, Classified
Z-2702-2024 Class IIMedline medical procedure kits labeled as follows: DENTAL, REF DYNJ909211AA slight dimensional variation which has the potential for increased difficulty fitting into outer canister. 03/22/2024Open, Classified
Z-2703-2024 Class IIMedline medical procedure kits labeled as follows: a) BASIC NASAL, REF DYNJ909932; b)…A slight dimensional variation which has the potential for increased difficulty fitting into outer canister. 03/22/2024Open, Classified
Z-2704-2024 Class IIMedline medical procedure kits labeled as follows: a) CYSTO, REF DYNJ905000D; b) ENDO…A slight dimensional variation which has the potential for increased difficulty fitting into outer canister. 03/22/2024Open, Classified
Z-2705-2024 Class IIMedline medical procedure kits labeled as follows: a) ENDO KIT, REF DYK1012268E1A slight dimensional variation which has the potential for increased difficulty fitting into outer canister. 03/22/2024Open, Classified
Z-2706-2024 Class IIMedline medical procedure kits labeled as follows: a) ENDO KIT, REF DYKE1410AA slight dimensional variation which has the potential for increased difficulty fitting into outer canister. 03/22/2024Open, Classified
Z-2707-2024 Class IIMedline medical procedure kits labeled as follows: a) MAJOR BREAST, REF DYNJ905004C; b)…A slight dimensional variation which has the potential for increased difficulty fitting into outer canister. 03/22/2024Open, Classified
Z-2708-2024 Class IIMedline medical procedure kits labeled as follows: a) AAA CDS, REF CDS984011C; b) CAN…A slight dimensional variation which has the potential for increased difficulty fitting into outer canister. 03/22/2024Open, Classified
Z-2709-2024 Class IIMedline medical procedure kits labeled as follows: a) KIT CANISTER SUCT W 12FT, REF…A slight dimensional variation which has the potential for increased difficulty fitting into outer canister. 03/22/2024Open, Classified
Z-2710-2024 Class IIMedline medical procedure kits labeled as follows: a) TURNOVER KIT, REF DYKC1289FA slight dimensional variation which has the potential for increased difficulty fitting into outer canister. 03/22/2024Open, Classified
Z-2711-2024 Class IIMedline medical procedure kits labeled as follows: a) BASIC NEURO, REF DYNJ909171A; b)…A slight dimensional variation which has the potential for increased difficulty fitting into outer canister. 03/22/2024Open, Classified
Z-2712-2024 Class IIMedline medical procedure kits labeled as follows: a) GYN CDS, REF DYNJ905499B; b) GYN…A slight dimensional variation which has the potential for increased difficulty fitting into outer canister. 03/22/2024Open, Classified
Z-2713-2024 Class IIMedline medical procedure kits labeled as follows: a) C-SECTION CDS, REF CDS983998CA slight dimensional variation which has the potential for increased difficulty fitting into outer canister. 03/22/2024Open, Classified
Z-2714-2024 Class IIMedline medical procedure kits labeled as follows: a) ARTHROSCOPY, REF DYNJ909699; b)…A slight dimensional variation which has the potential for increased difficulty fitting into outer canister. 03/22/2024Open, Classified