MEDLINE ARTERIAL LINE PACK, REF DYNJ65208B, medical convenience kit containing Infusion Catheter with Antimicrobial Hepa

FDA device recall Z-1049-2025 · posted 2025-01-29 · Open, Classified

Recall details

Recalling firm

MEDLINE INDUSTRIES, LP - Northfield

Reason for recall

Certain lots Sterile Infusion Catheters which were mislabeled as having a heparin coating were either distributed or manufactured into medical convenience kits and distributed.

Action taken

Medline Industries, LP issued one IMMEDIATE ACTION REQUIRED notice and one MEDICAL DEVICE RECALL notice to its affected consignees on 12/23/2024 via email and US Mail. The IMMEDIATE ACTION REQUIRED notice explained the labeling issue with the device, potential risk, and requested the following actions be taken: 1. affected catheters be quarantined, 2. respond with quantity on hand, 3. if the product was transferred to notify those to whom the affected catheters were transferred. Upon receipt of the response. Medline will issue corrected labeling to affix to the devices. The MEDICAL DEVICE RECALL notice, which pertains to kits manufactured with the affected catheters as a component, also explained the labeling issue with the device, potential risk, and requested the following actions be taken: 1. affected catheters be quarantined, 2. respond with quantity on hand, 3. if the product was transferred to notify those to whom the affected catheters were transferred. Upon receipt of the response. Medline will issue a label to affix to the devices which will state the affected component shall be removed and discarded from further use.

Root cause

Process change control

Status

Open, Classified

Product code

LRO

Quantity affected

50 units

Distribution

US: FL, KS, ND, PA, WA, WV, IL, WA

Date initiated

2024-12-23

Date posted

2025-01-29

Location

Northfield, IL

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