—#207023

Product

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, REF DYNJ905509F; e) GYN LAPAROSCOPY II, REF DYNJS2030F; f) LAP ROBOTIC, REF DYNJ902384K; g) LAPAROSCOPY-ROBOT, REF DYNJ905003C; h) ROBOTIC, REF DYNJ907156A

FDA product code: OHD — Gynecological Laparoscopic Kit
Device class: Class 2
Medical specialty: Obstetrics/Gynecology
Affected 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

Why it was recalled

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

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: MEDLINE INDUSTRIES, LP Northfield
Address: 3 Lakes Dr, Northfield, Illinois 60093-2753

Distribution

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

Timeline

Recall initiated: 2024-03-22
Posted by FDA: 2024-08-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #207023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.