Recall Z-3112-2024
MEDLINE INDUSTRIES, LP - Northfield · initiated June 27, 2024
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Medline convenience kits containing semi-rigid suction liners labeled as follows: a) ENDO KIT, Pack Number DYKE1350D; b) ENDO KIT, Pack Number DYKE1514B
Codes / lots: a) DYKE1350D: UDI/DI case 40193489339797, UDI.DI each 10193489339796; Lot Numbers: 24CBG448, 24EBF166; b) DYKE1514B: UDI/DI case 40193489797832, UDI.DI each 10193489797831; Lot Numbers: 24CBR722, 24FBA408
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.
FDA-determined 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.
Details
- Recall number
- Z-3112-2024
- Initiated
- June 27, 2024
- Posted by FDA
- September 11, 2024
- Product code
- PPB – Foley Catheter Kit (Excludes Hiv Testing)
- Quantity
- 1616 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Panama.
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-3105-2024 Class II | Medline Semi-rigid suction liners labeled as follows: a) SEMI RIGID SUCTION LINER, REF…Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and lots of… | 06/27/2024Open, Classified |
| Z-3106-2024 Class II | Medline convenience kits containing semi-rigid suction liners labeled as follows: a)…Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and lots of… | 06/27/2024Open, Classified |
| Z-3107-2024 Class II | Medline convenience kits containing semi-rigid suction liners labeled as follows: a)…Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and lots of… | 06/27/2024Open, Classified |
| Z-3108-2024 Class II | Medline convenience kits containing semi-rigid suction liners labeled as follows:…Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and lots of… | 06/27/2024Open, Classified |
| Z-3109-2024 Class II | Medline convenience kits containing semi-rigid suction liners labeled as follows: a)…Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and lots of… | 06/27/2024Open, Classified |
| Z-3110-2024 Class II | Medline convenience kits containing semi-rigid suction liners labeled as follows: a)…Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and lots of… | 06/27/2024Open, Classified |
| Z-3111-2024 Class II | Medline convenience kits containing semi-rigid suction liners labeled as follows: a)…Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and lots of… | 06/27/2024Open, Classified |
| Z-3113-2024 Class II | Medline convenience kits containing semi-rigid suction liners labeled as follows: a)…Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and lots of… | 06/27/2024Open, Classified |
| Z-3114-2024 Class II | Medline convenience kits containing semi-rigid suction liners labeled as follows: a)…Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and lots of… | 06/27/2024Open, Classified |
| Z-3115-2024 Class II | Medline convenience kits containing semi-rigid suction liners labeled as follows: NICU…Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and lots of… | 06/27/2024Open, Classified |
| Z-3116-2024 Class II | Medline convenience kits containing semi-rigid suction liners labeled as follows: ANES…Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and lots of… | 06/27/2024Open, Classified |
| Z-3117-2024 Class II | Medline convenience kits containing semi-rigid suction liners labeled as follows: KIT…Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and lots of… | 06/27/2024Open, Classified |
| Z-3118-2024 Class II | Medline convenience kits containing semi-rigid suction liners labeled as follows: MTHZ…Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and lots of… | 06/27/2024Open, Classified |
| Z-3119-2024 Class II | Medline convenience kits containing semi-rigid suction liners labeled as follows: MERCY…Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and lots of… | 06/27/2024Open, Classified |
| Z-3120-2024 Class II | Medline convenience kits containing semi-rigid suction liners labeled as follows: a) AMB…XXX | 06/27/2024Open, Classified |
| Z-3121-2024 Class II | Medline convenience kits containing semi-rigid suction liners labeled as follows: a)…Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and lots of… | 06/27/2024Open, Classified |