—#207009

Product

Medline medical procedure kits labeled as follows: a) ANESTHESIA CIRCUIT ADULT, REF DYNJAAF6666B; b) ANESTHESIA CIRCUIT PEDS-LF, REF DYNJAP9918A; c) CV ANESTHESIA - ROOM SET UP, REF DYNJ905503F

FDA product code: CAI — Circuit, Breathing (W Connector, Adaptor, Y Piece)
Device class: Class 1
Medical specialty: Anesthesiology
Affected lot / code info: a) REF DYNJAAF6666B, UDI/DI 40195327505838 (case), 10195327505837 (unit), Lot Numbers: 22EBD700, 22GBK692, 22KBE980, 23DBF522, 23GBU504, 23IBJ329, 23LBD558; b) REF DYNJAP9918A, UDI/DI 40195327505883 (case), 10195327505882 (unit), Lot Numbers: 22EBC460, 22HBK483, 22IBT280, 22JBC030, 22KBG647, 23IBM414; c) REF DYNJ905503F, UDI/DI 40889942131410 (case), 10889942131419 (unit), Lot Numbers: 22FBR267, 22GBR286, 22HBS560, 22IBA577, 22JBI883, 22KBD587, 22LBF425, 23BBN903, 23CBL450, 23CBW776, 23FBC209, 23IBU343, 23JBP494, 23KBH749, 23KBQ236

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 #207009. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.