Z-1568-2015Class II
3/16 in. Round Drain with Trocar Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved...
Stryker Corp. / initiated 2015-03-26 / Terminated / root cause: packaging
Stryker Instruments Div. of Stryker Corporation began a recall of 3/16 in. Round Drain with Trocar Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved trocar wound drain has a curved metal trocar... on . FDA classified it as Class II and gives the reason as "Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential sterility breach in the packaging". As of , the recall status on record is Terminated, and MDM tags the root cause as packaging.
Recall record
- Recall number
- Z-1568-2015
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Stryker Corp.
- Product
- 3/16 in. Round Drain with Trocar Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved trocar wound drain has a curved metal trocar attached to one end of the flexible wound drain tube. There is also a polymeric trocar guard that provides protection from the sharp end of the trocar during handling. The double trocar wound drain has metal trocars on either side of the flexible wound drain tube. These are also equipped with trocar guards.
- Product code
- GCY Apparatus, Suction, Single Patient Use, Portable, Nonpowered
- Reason for recall
- Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential sterility breach in the packaging
- Root cause tag
- packaging
- FDA root cause
- Package design/selection
- Action
- An URGENT MEDICAL DEVICE NOTIFICATION letter was sent to all customers on 03/31/2015. The letter identified the affected product, the reason for the recall, the risk to health, and actions to be taken by the customer or user. All are asked to sign the Business Reply Form stating they have read the Notification and followed all instructions within. Customers were asked to immediately check all inventory and quarantine any affected product, return affected product to Stericycle for destruction using a return label provided by Stericycle. Upon receipt of affected product a credit will be issued to customer account.
- Quantity in commerce
- 648 boxes (6,480 each)
- Distribution
- Worldwide Distribution. US nationwide, Australia, Great Britain, The Netherlands, Spain, Romania, Greece, Switzerland, South Africa, and Japan.
- Product codes and lots
- Part Number: 0215-031-000 and lot numbers: 10074012 10231012 10337012 11122012 11348012 12172012 13081012 14044012 10104012 10263012 11012012 11185012 12053012 12237012 13126012 14147012 10147012 10279012 11055012 11216012 12082012 12318012 13163012 14153012 10153012 10309012 11110012 11252012 12116012 12331012 13211012
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1562-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1563-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1564-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1565-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1566-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1567-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1568-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1569-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1570-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1571-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1572-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1573-2015 | Class II | Terminated | Voluntary: Firm initiated |
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