Medline procedural kits labeled as: 1) ANESTHESIA CIRCUIT PEDS-LF, Pack Number DYNJAA0327F; 2) ANESTHESIA...
MEDLINE INDUSTRIES, LP - Northfield began a recall of Medline procedural kits labeled as: 1) ANESTHESIA CIRCUIT PEDS-LF, Pack Number DYNJAA0327F; 2) ANESTHESIA CIRCUIT PEDS-LF, Pack Number DYNJAA0327G on . FDA classified it as Class II and gives the reason as "Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health". As of , the recall status on record is Open, Classified.
Recall record
- Recall number
- Z-2739-2024
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Product
- Medline procedural kits labeled as: 1) ANESTHESIA CIRCUIT PEDS-LF, Pack Number DYNJAA0327F; 2) ANESTHESIA CIRCUIT PEDS-LF, Pack Number DYNJAA0327G
- Product code
- CAI Circuit, Breathing (W Connector, Adaptor, Y Piece)
- Reason for recall
- Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
- FDA root cause
- Under Investigation by firm
- Action
- Medline Industries LP issued a recall notice to its consignees on 04/08/2024 via letter delivered via USPS and email. The notice explained the issue, provided a link to for information pertaining to the risk involved https://www.fda.gov/medical-devices/safety-communications/update-evaluating-plastic-syringes-made-china-potential-device-failures-fda-safety-communication) and request the syringes within the convenience be discarded, except for circumstances where no alternative syringes are readily available. If these syringes must be used, closely monitor for leaks, breakage, and any other problems, and report any quality issues to Medline and the FDA. Distributors were directed to notify their customers. The firm issued a second recall notice (an expansion) on 05/02/2024 using the same methods.
- Distribution
- Worldwide
- Product codes and lots
- DYNJAA0327F , Lot Number 20LBV329 ; DYNJAA0327G , Lot Number 21FBM358 ; DYNJAA0327G , Lot Number 22CBY412 ; DYNJAA0327G , Lot Number 22GBZ157 ; DYNJAA0327G , Lot Number 22JBR268 ; DYNJAA0327G , Lot Number 23BBL309 ; DYNJAA0327G , Lot Number 23HBU238 ; DYNJAA0327G , Lot Number 23KBB605 ; DYNJAA0327G , Lot Number 24CBJ211 ;
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-2739-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2740-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2741-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2742-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2743-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2744-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2745-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2746-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2747-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2748-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2749-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2750-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2751-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2752-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2753-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2754-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2755-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2756-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2757-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2758-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2759-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2760-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2761-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2762-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2763-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2764-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2765-2024 | Class II | Ongoing | Voluntary: Firm initiated |
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