Medline Kits, trays, and packs labeled as follows: a) KIT,SUCTION CATH,10FR W/WATER, REF DYND41470; b) KIT,SUCTION CATH,12FR W/H20 12, REF DYND41471; c) KIT,SUCTION CATH,14FR W/SALIN, REF DYND40442; d) KIT,SUCTION CATH,14FR W/WATER, REF DYND41472; e) KIT,SUCTION CATH,18FR W/H20, REF DYND41474; f) KIT,SUCTION CATH,6FR,DELEE,W/H, REF DYND41476; g) KIT,SUCTION CATH,8FR DELEE W/H, REF DYND41478; h) KIT,SUCTION CATHETER,14FR W/S, REF DYND41442
FDA Recall Z-1128-2024 · Posted 2024-02-25
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Recalling FirmMEDLINE INDUSTRIES, LP - Northfield
Recall StatusOpen, Classified
Product CodeJOL
Date Initiated2023-11-15
Product Quantity1,012,700 units
Reason for Recall
Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.
Firm Action
MEDLINE issued an IMMEDIATE ACTION REQUIRED NURSE ASSIST PRODUCT RECALL notice to its consignees on 11/16/2023 via USPS first class mail and email. The notice explained the problem, requested log on to their portal to identify the products and check their inventory so the product could be quarantined. Once Medline receives the completed response form, over-labels will be shipped to the consignee. Medline Industries, LP instructed customers to over-label the convenience kits with a warning label indicating to remove the sodium chloride irrigation or Sterile water and replace from a different sterile supply. Distributors or consignees who further distributed the affected products were directed to notify their customers.
For questions, contact the Recall Department at 866-359-1704 or [email protected].
Root Cause
Nonconforming Material/Component
Distribution Pattern
Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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