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Open, Classified

Medline medical procedure kits labeled as follows: a) BASIC NASAL, REF DYNJ909932; b) BRONCH KIT, REF DYKE1007B; c) ENT, REF DYNJ909935; d) NASAL SINUS-LF, REF DYNJ902624G; e) ORAL, REF DYNJ902377I; f) PACK,BRONCHOSCOPY, REF DYNJ65475B; g) PACK,HEAD AND NECK, REF DYNJ65487B; h) PACK,SINUS, REF DYNJ906898; i) PACK,T & A, REF DYNJ906897B; j) PACK,T & A ASC, REF DYNJ906914; k) T AND A, REF DYNJ909941

FDA Recall Z-2703-2024 · Posted 2024-08-22

Recalling FirmMEDLINE INDUSTRIES, LP - Northfield
Recall StatusOpen, Classified
Product CodeOGR
Date Initiated2024-03-22
Product Quantity6998 units

Reason for Recall

A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.

Firm Action

Medline Industries issued a Safety Alert to its consignees on 03/22/2024 via email and certified mail. The notice explained the problem with the device and requested that consignees follow the instructions for use. Distributors or those who further transferred the affected product were directed to notify their consignees.

Root Cause

Under Investigation by firm

Distribution Pattern

Worldwide - US Nationwide and the countries of Panama, Mexico, Canada, Qatar, El Salvador, Oman, Colombia, Singapore.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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