Medline brand, medical procedure convenience kits, labeled as: a) RADIOLOGY LP TRAY, REF DYNDH1609; b) CARDIAC CATH PACK-LF, REF DYNJ19010I; c) SUPPLEMENTAL NEURO ANGIO PK, REF DYNJ29207; d) ANGIO PACK, REF DYNJ43661C; e) LEFT HEART CATH TEGH-LF, REF DYNJ46746C; f) LFT HRT CATH RADIAL ACCESS-LF, REF DYNJ47667C; g) IR ARM PACK, REF DYNJ50712D; h) IR PACK, REF DYNJ67324; i) PL. CATHETERISME CARDIAQUE, REF HCT093J
This recall is currently active, issued October 23, 2024. It was issued by Medline Industries, Lp - Northfield.
- Recall Initiated
- September 4, 2024
- Posted
- October 23, 2024
- Recall Number
- Z-0155-2025
- Quantity
- 1460 units
- Firm Location
- Northfield, IL
- Official Source
- View on FDA website ↗
Reason for Recall
It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Panama.
Lot / Code Info
a) REF DYNDH1609: UDI/DI 40193489844802 (each), 10193489844801 (case), Lot Numbers: 23LBO852; b) REF DYNJ19010I: UDI/DI 40888277858627 (each), 10888277858626 (case), Lot Numbers: 23LBK443; c) REF DYNJ29207: UDI/DI 40080196015413 (each), 10080196015412 (case), Lot Numbers: 23LBL962; d) REF DYNJ43661C: UDI/DI 40195327104353 (each), 10195327104351 (case), Lot Numbers: 23LBU931; e) REF DYNJ46746C: UDI/DI 40195327040162 (each), 10195327040161 (case), Lot Numbers: 23LBK374; f) REF DYNJ47667C: UDI/DI 40195327040179 (each), 10195327040178 (case), Lot Numbers: 23LBL629; g) REF DYNJ50712D: UDI/DI 40195327267927 (each), 10195327267926 (case), Lot Numbers: 23KBE846; h) REF DYNJ67324: UDI/DI 40193489395625 (each), 10193489395624 (case), Lot Numbers: 23LBL780; i) REF HCT093J: UDI/DI 40884389905679 (each), 10884389905678 (case), Lot Numbers: 23LBG513
Root Cause
Under Investigation by firm
Action Taken
Medline issued a MEDICAL DEVICE RECALL notice to its consignees on 09/05/2024 via email and USPS. The notice explained the issue, hazard, and requested the destruction of the affected product. Distributors were directed to notify their consignees.