Medline Semi-rigid suction liners labeled as follows: a) SEMI RIGID SUCTION LINER, REF OR515; b) SEMI RIGID SUCTION LINER WITH TUBING, REF OR526K; c) SEMI RIGID SUCTION LINER WITH TUBING, REF OR527K; d) SEMI RIGID SUCTION LINER WITH TUBING, REF OR529K
This recall is currently active, issued September 11, 2024. It was issued by Medline Industries, Lp - Northfield.
- Recall Initiated
- June 27, 2024
- Posted
- September 11, 2024
- Recall Number
- Z-3105-2024
- Quantity
- 1,250,374 units
- Firm Location
- Northfield, IL
- Official Source
- View on FDA website ↗
Reason for Recall
Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and lots of 1500 cc semi-rigid liners manufactured from 09/2023-11/2023 due to the potential loss of suction or low suction during intermittent suction use.
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Panama.
Lot / Code Info
a) OR515: UDI/DI 10884389968093, Lot Numbers: 93023082618C, 93023082730C, 93023090602C, 93023090902C, 93023091309C, 93023091409C, 93023091428C, 93023091506C, 93023091609C, 93023091806C, 93023093A10C, 93023098426C, 93023098623C, 93023098811C, 93023099605C, 93023099705C, 93023099806C, 93023099826C, 93023102613C, 93023102718C, 93023102815C, 93023102920C, 93023103015C, 93023103120C, 93023103316C, 93023103B08C, 93023106628C, 93023106721C, 93023107028C, 93023107225C, 93023108512C, 93023108712C, 93023112721C, 93023112828C, 93023113027C, 93023113327C, 93023113626C, 93023113C12C, 93023116906C, 93023117013C, 93023117106C, 93023117118C, 93023117212C, 93023117301C, 93023117317C, 93023117401C, 93023117420C, 93023117506C, 93023117512C, 93023117618C, 93023117721C, 93023117806C, 93023117917C, 93023118018C, 93023123D02C, 93024013602D; b) OR526K: UDI/DI 10888277253087, Lot Numbers: 93023103026C, 93023103126C, 93023106626C, 93023113621C, 93023113725C, 93023116708C, 93023117809C, 93023117920C, 93023118025C; c) OR527K: UDI/DI 10888277253094, Lot Numbers: 93023091427C, 93023093227C, 93023093327C, 93023098827C, 93023106629C, 93023113615C, 93023116708C, 93023117815C, 93023117817C, 93023117915C; d) OR529K: UDI/DI 10888277253100, Lot Numbers: 93023091709C, 93023091824C, 93023092709C, 93023098824C, 93023101409C, 93023103209C, 93023103309C, 93023106629C, 93023116710C, 93023117815C, 93023117922C, 93023118022C, 93023124606C.
Root Cause
Process control
Action Taken
Medline Industries issued a MEDICAL DEVICE RECALL notice to its consignees on 06/27/2024 via US mail and email. The notice explained the problem with the device, potential risk to the patient, and requested the consignee immediately check their stock for the affected item number and the affected lot numbers and destroy any affected inventory. Distributors were directed to notify their customers of the recall and request the affected products be destroyed. For questions: contact the Recall Department at 866-359-1704 or recalls@medline.com.