Magic3 Go Intermittent Urinary Catheters, pediatric Catalog Numbers: a) REF 52810G
C.R. Bard Inc began a recall of Magic3 Go Intermittent Urinary Catheters, pediatric Catalog Numbers: a) REF 52810G on . FDA classified it as Class II and gives the reason as "Some catheters had a manufacturing defect where the clear resealing label separating from the product foil pouch, resulting in a possible opening into the product packaging that could impact product sterility". As of , the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.
Recall record
- Recall number
- Z-1700-2023
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- C.R. Bard Inc
- Product
- Magic3 Go Intermittent Urinary Catheters, pediatric Catalog Numbers: a) REF 52810G
- Product code
- EZD Catheter, Straight
- Reason for recall
- Some catheters had a manufacturing defect where the clear resealing label separating from the product foil pouch, resulting in a possible opening into the product packaging that could impact product sterility.
- Root cause tag
- labeling and UDI
- FDA root cause
- Under Investigation by firm
- Action
- The firm issued an URGENT MEDICAL DEVICE RECALL to its consignee beginning on 04/20/2023 by Fed Ex and email. The notice explained the problem, risk, and requested the following actions be taken: Discontinue distribution of the product and dispose of all affected product, Distributors are directed to notify their customers. For further assistance please contact: 1-844-8BD- LIFE (1-844-823-5433) Say "Recall" when prompted; M-F 8am - 5pm CT
- Quantity in commerce
- 5760 devices
- Distribution
- Worldwide
- Product codes and lots
- a) REF 52810G, UDI/DI 00801741136870, Lot Numbers: JUGW1445
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1698-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1699-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1700-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1701-2023 | Class II | Ongoing | Voluntary: Firm initiated |
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