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FDA (Device enforcement)Recalled 2024-03-22class ii

MEDLINE INDUSTRIES, LP - Northfield: Medline medical procedure kits labeled as follows: a) GYN CDS, REF DYNJ905499B; b) GYN LAP, REF DYNJ909936; c) GYN LAPAROSCOPY, REF DYNJ902371J; d) GYN LAPAROSCOPY

Hazard

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

Details from the source

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. Quantity: 964 units Lot/code info: a) REF DYNJ905499B, UDI/DI 40195327316915 (case), 10195327316914 (unit), Lot Numbers: DYNJ905499B, DYNJ905499B, DYNJ905499B, DYNJ905499B; b) REF DYNJ909936, UDI/DI 40195327511204 (case), 10195327511203 (unit), Lot Numbers: 23JBI037, 23KBP829; c) REF DYNJ902371J, UDI/DI 40195327505821 (case), 10195327505820 (unit), Lot Numbers: 23JBU910, 23LBM411; d) REF DYNJ905509F, UDI/DI 40195327269082 (case), 10195327269081 (unit), Lot Numbers: 22LMF016, 23CMH468, 23FMC902; e) REF DYNJS2030F, UDI/DI 40195327386499 (case), 10195327386498 (unit), Lot Numbers: 23EDB982, 23HDA434, 23JDA055; f) REF DYNJ902384K, UDI/DI 40195327503988 (case), 10195327503987 (unit), Lot Numbers: 23KBR180; g) REF DYNJ905003C, UDI/DI 40195327316922 (case), 10195327316921 (unit), Lot Numbers: 23BBP719, 23BBR580, 23DBM969, 23EBT058, 23FBS331, 23GBS886, 23HBP436, 23JBB060, 23LBF305, 23LBP294; h) REF DYNJ907156A, UDI/DI 40193489970266 (case), 10193489970265 (unit), Lot Numbers: 22EME051, 22FMF571, 22GME222, 22KMF942, 22KMF944, 23AMG688, 23BMF088, 23IME181, 23KMF153

UPC codes

40195327316915, 10195327316914, 40195327511204, 10195327511203, 40195327505821, 10195327505820, 40195327269082, 10195327269081, 40195327386499, 10195327386498, 40195327503988, 10195327503987, 40195327316922, 10195327316921, 40193489970266, 10193489970265

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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