Z-1472-2021Class II
Left Heart Kit, Model Number M20268. for blood pressure monitoring
Abbott Medical / initiated 2021-03-31 / Terminated / root cause: manufacturing process
Smiths Medical ASD Inc. began a recall of Left Heart Kit, Model Number M20268. for blood pressure monitoring on . FDA classified it as Class II and gives the reason as "Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Medex LogiCal Kits may have been manufactured with insufficient or incomplete welds. These are components for various cardiac...". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-1472-2021
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Abbott Medical
- Product
- Left Heart Kit, Model Number M20268. for blood pressure monitoring.
- Product code
- NEP System/Device, Pharmacy Compounding
- Reason for recall
- Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Medex LogiCal Kits may have been manufactured with insufficient or incomplete welds. These are components for various cardiac kits including pressure monitoring devices and interventional imaging devices.
- Root cause tag
- manufacturing process
- FDA root cause
- Process control
- Action
- The firm initiated the action by email on 03/31/2021. The Recall Notice instructs consignees to identify, and quarantine affected product in their possession. A list of affected product has been included on the Recall Notice for consignees to identify affected product. The consignees have been instructed to complete the response form, and return it to [email protected] within 10 days of receipt. After the completed Recall Response Form has been submitted to [email protected], the consignee will be contacted to arrange return of any affected product in their possession. Distributors have been instructed that if they have distributed potentially affected product to their customers to immediately notify them of the Recall.
- Quantity in commerce
- 600 devices
- Distribution
- Distribution US nationwide including Puerto Rico, Austria, Canada, Chile, Ecuador, Hong Kong, Mexico, Slovenia, Brazil, South Africa, Colombia, and Japan.
- Product codes and lots
- Lot Numbers: 4002486, 4019146, 4036647
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1470-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1471-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1472-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1473-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1474-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1475-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1476-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1477-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1478-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1479-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1480-2021 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1481-2021 | Class II | Terminated | Voluntary: Firm initiated |
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