Z-2756-2024Class II
Medline procedural kits labeled as: 1) CIRCUMCISION TRAY, Pack Number CIT6715; 2) NICU CIRCUMCISION TRAY...
MEDLINE INDUSTRIES, LP - Northfield / initiated 2024-04-08 / Open, Classified
MEDLINE INDUSTRIES, LP - Northfield began a recall of Medline procedural kits labeled as: 1) CIRCUMCISION TRAY, Pack Number CIT6715; 2) NICU CIRCUMCISION TRAY W/OUT CLAMP, Pack Number CIT6920; 3) OSF SMMC... 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-2756-2024
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Product
- Medline procedural kits labeled as: 1) CIRCUMCISION TRAY, Pack Number CIT6715; 2) NICU CIRCUMCISION TRAY W/OUT CLAMP, Pack Number CIT6920; 3) OSF SMMC CIRCUMCISION KIT, Pack Number CIT7095; 4) RETINAL INJECTION KIT, Pack Number MNS12465; 5) UCLA - BREAST BIOPSY KIT, Pack Number DYNDH1512
- Product code
- PXP Breast Biopsy / Localization Tray
- 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
- CIT6715, Lot Number 2023071390; CIT6920, Lot Number 2021071290; CIT7095, Lot Number 2021071290; CIT7095, Lot Number 2022110390; MNS12465, Lot Number 2023081590; DYNDH1512, Lot Number 2021070790; DYNDH1512, Lot Number 2021080290; DYNDH1512, Lot Number 2022011990; DYNDH1512A, Lot Number 2022110390; DYNDH1512A, Lot Number 2023052290; DYNDH1512A, Lot Number 2023071390; DYNDH1512A, Lot Number 2024022690
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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