Device 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
Z-2700-2024
Product summary
- Event
- Event 94356
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1920 units
- Official record key
device-enforcement:Z-2700-2024
Official wording
Reason: A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
Code information: 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
Distribution pattern: Worldwide - US Nationwide and the countries of Panama, Mexico, Canada, Qatar, El Salvador, Oman, Colombia, Singapore.
Derived failure modes
-
Unknown
A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.