FDAClass IIAugust 28, 2024

Medline medical procedure kits labeled as follows: a) recall

Medline medical procedure kits labeled as follows: a) GYN CDS, REF DYNJ905499B; b) GYN LAP, REF DYNJ909936; c) GYN LAPAROSCOPY, REF DYNJ902371J; d)…

Why was Medline medical procedure kits labeled as follows: a) recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Medline medical procedure kits labeled as follows: a) GYN CDS, REF DYNJ905499B; b) GYN LAP, REF DYNJ909936; c) GYN LAPAROSCOPY, REF DYNJ902371J; d)…
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Quantity
964 units
Distribution
Worldwide - US Nationwide and the countries of Panama, Mexico, Canada, Qatar, El Salvador, Oman, Colombia, Singapore.
Recall date
August 28, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls