Z-1570-2015Class II
3/16 in. Curved Trocar with Wound Drain Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The...
Stryker Corp. / initiated 2015-03-26 / Terminated / root cause: packaging
Stryker Instruments Div. of Stryker Corporation began a recall of 3/16 in. Curved Trocar with Wound Drain 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-1570-2015
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Stryker Corp.
- Product
- 3/16 in. Curved Trocar with Wound Drain 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
- CAC Apparatus, Autotransfusion
- 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
- 628 boxes (6,280 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: 0225-015-000 and lot numbers: 10083012 10349012 11224012 12151012 13092012 13196012 14034012 14246012 10125012 11014012 11257012 12286012 13119012 13248012 14127012 14263012 10162012 11059012 12039012 12341012 13135012 13274012 14165012 10273012 11108012 12075012 13010012 13172012 13326012 14177012 10309012 11160012 12080012 13065012 13191012 14021012 14231012
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 |
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.