Z-2700-2024Class II
Medline medical procedure kits labeled as follows: a) ANESTHESIA CIRCUIT ADULT, REF DYNJAAF6666B; b)...
MEDLINE INDUSTRIES, LP - Northfield / initiated 2024-03-22 / Open, Classified
MEDLINE INDUSTRIES, LP - Northfield began a recall of Medline medical procedure kits labeled as follows: a) ANESTHESIA CIRCUIT ADULT, REF DYNJAAF6666B; b) ANESTHESIA CIRCUIT PEDS-LF, REF DYNJAP9918A; c) CV... on . FDA classified it as Class II and gives the reason as "A slight dimensional variation which has the potential for increased difficulty fitting into outer canister". As of , the recall status on record is Open, Classified.
Recall record
- Recall number
- Z-2700-2024
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- 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
- Product code
- CAI Circuit, Breathing (W Connector, Adaptor, Y Piece)
- Reason for recall
- A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
- FDA root cause
- Under Investigation by firm
- Action
- 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.
- Quantity in commerce
- 1920 units
- Distribution
- Worldwide - US Nationwide and the countries of Panama, Mexico, Canada, Qatar, El Salvador, Oman, Colombia, Singapore.
- Product codes and lots
- 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
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-2694-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2695-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2696-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2697-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2698-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2699-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2700-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2701-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2702-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2703-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2704-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2705-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2706-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2707-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2708-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2709-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2710-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2711-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2712-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2713-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2714-2024 | Class II | Ongoing | Voluntary: Firm initiated |
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.