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Medline medical procedure kits labeled as follows recallZ-2703-2024 · MEDLINE INDUSTRIES, LP - Northfield · initiated Mar 22, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from MEDLINE INDUSTRIES, LP - Northfield or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Under Investigation by firm

What the company is doing

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.

Recall details

Recall number
Z-2703-2024
Status
Open, Classified
Initiated by the company
Mar 22, 2024
Posted by the FDA
Aug 22, 2024
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Quantity
6998 units
Product code
OGR
Distribution
Worldwide - US Nationwide and the countries of Panama, Mexico, Canada, Qatar, El Salvador, Oman, Colombia, Singapore.

Product description

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

Code information (models, lots, serial numbers)

Show the full code information (2k characters)

a) REF DYNJ909932, UDI/DI 40195327511167 (case), 10195327511166 (unit), Lot Numbers: 23JBI290, 23KBI103; b) REF DYKE1007B, UDI/DI 40195327203697 (case), 10195327203696 (unit), Lot Numbers: 22HBF709, 22HBV977, 22LBC080, 22LBH793, 23CBP363, 23DBL601, 23EBT148, 23FBS311, 23GBP583, 23HBY932, 23JBK265,; c) REF DYNJ909935, UDI/DI 40195327511198 (case), 10195327511197 (unit), Lot Numbers: 23JBH869; d) REF DYNJ902624G, UDI/DI 40195327214525 (case), 10195327214524 (unit), Lot Numbers: 22IBA877, 22IBN753, 23DBG397, 23FBN458, 23GBG939, 23HBT691, 23JBQ259, 23KBO185; e) REF DYNJ902377I, UDI/DI 40195327505883 (case), 10195327505882 (unit), Lot Numbers: 23JBI663; f) REF DYNJ65475B, UDI/DI 40195327303519 (case), 10195327303518 (unit), Lot Numbers: 22LBE939, 23ABK037, 23BBI110, 23CBH860, 23DBF474, 23DBS953, 23GBN857, 23JBE718, 23KBL576; g) REF DYNJ65487B, UDI/DI 40195327303663 (case), 10195327303662 (unit), Lot Numbers: 22LBP408, 23ABN443, 23CBM523, 23DBM713, 23IBM894; h) REF DYNJ906898, UDI/DI 40193489281928 (case), 10193489281927 (unit), Lot Numbers: 22HBA414, 22JBR764, 23FBK308, 23GBC593, 23IBF940, 23KBO165, 23KBT057; i) REF DYNJ906897B, UDI/DI 40195327373147 (case), 10195327373146 (unit), Lot Numbers: 23EBE963, 23EBL760, 23FBC942, 23FBC943, 23HBQ553, 23HBS215, 23IBD903, 23KBE192, 23KBI100, 23LBH012; j) REF DYNJ906914, UDI/DI 40193489280174 (case), 10193489280173 (unit), Lot Numbers: 22EBS455, 22EBU139, 22GBK146, 22HBG371, 22JBG419, 22KBI283, 23ABC387, 23CBI473, 23CBO589, 23CBU019, 23EBE957, 23EBV972, 23GBB581, 23IBP952, 23IBV288, 23JBB697, 23LBJ608; k) REF DYNJ909941, UDI/DI 40195327511006 (case), 10195327511005 (unit), Lot Numbers: 23JBH984

Devices named in this recall

11 devices in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 94356).

Sources and updates

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