Z-2418-2023Class II
Snowden-Pencer MIS DIAMOND-TOUCH DISSECTOR FENESTRATED 16MM JAW 5MM, 32CM, NON RATCHETED, REF SP90-7036...
Medtronic, Inc. / initiated 2023-07-13 / Open, Classified / root cause: manufacturing process
Carefusion 2200 Inc began a recall of Snowden-Pencer MIS DIAMOND-TOUCH DISSECTOR FENESTRATED 16MM JAW 5MM, 32CM, NON RATCHETED, REF SP90-7036; endoscopic surgical device on . FDA classified it as Class II and gives the reason as "Specific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to the incorrect use of an adhesive in the manufacturing process". As of , the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-2418-2023
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- Medtronic, Inc.
- Product
- Snowden-Pencer MIS DIAMOND-TOUCH DISSECTOR FENESTRATED 16MM JAW 5MM, 32CM, NON RATCHETED, REF SP90-7036; endoscopic surgical device
- Product code
- GCJ Laparoscope, General & Plastic Surgery
- Reason for recall
- Specific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to the incorrect use of an adhesive in the manufacturing process.
- Root cause tag
- manufacturing process
- FDA root cause
- Nonconforming Material/Component
- Action
- BD issued an URGENT: Medical Device Product Recall notice to its consignees on 13 July 2023 via FedEx 2-day and email. The notice explained the problem with the device, the risk to the patient, and requested the following actions: Medical facilities: - Discontinue the use of the affected device and destroy it - Share the notice with all users within your facility network - If the product was purchased through a distributor, contact the distributor directly for further instructions. Distributors were directed to Identify all customers within your distribution network that purchased any affected product as defined in this notification. Provide a copy of the attached customer letter to all customers to advise them of this recall notification on BD s behalf. Questions: Phone: 1-844-8BD- LIFE (1-844-823-5433), Say Recall when prompted, M-F 8am - 5pm CT Email: [email protected]
- Quantity in commerce
- 0 units
- Distribution
- US and Canada
- Product codes and lots
- UDI/DI 10885403159862, Lot Number B23
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-2415-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2416-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2417-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2418-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2419-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2420-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2421-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2422-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2423-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2424-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2425-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2426-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2427-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2428-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2429-2023 | Class II | Ongoing | Voluntary: Firm initiated |
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