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
This recall is currently active, issued August 22, 2024. It was issued by Medline Industries, Lp - Northfield.
- Recall Initiated
- March 22, 2024
- Posted
- August 22, 2024
- Recall Number
- Z-2703-2024
- Quantity
- 6998 units
- Firm Location
- Northfield, IL
- Official Source
- View on FDA website ↗
Reason for Recall
A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
Distribution
Worldwide - US Nationwide and the countries of Panama, Mexico, Canada, Qatar, El Salvador, Oman, Colombia, Singapore.
Lot / Code Info
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
Root Cause
Under Investigation by firm
Action Taken
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.