Z-0573-2008
Stryker Disposable StrykeProbe 32cm L- Tip, Ref: 250-070-550, Electrosurgical Suction Tip, Stryker Endoscopy...
Stryker Corp. / initiated 2007-11-16 / Terminated / root cause: design
Stryker Endoscopy began a recall of Stryker Disposable StrykeProbe 32cm L- Tip, Ref: 250-070-550, Electrosurgical Suction Tip, Stryker Endoscopy, San Jose, CA 95138 on . The reason FDA records is "Cannot connect: Tips have electrodes that are too large to fit monopolar cables and are unusable". As of , the recall status on record is Terminated, and MDM tags the root cause as design.
Recall record
- Recall number
- Z-0573-2008
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Stryker Corp.
- Product
- Stryker Disposable StrykeProbe 32cm L- Tip, Ref: 250-070-550, Electrosurgical Suction Tip, Stryker Endoscopy, San Jose, CA 95138.
- Product code
- GEI Electrosurgical, Cutting & Coagulation & Accessories
- Reason for recall
- Cannot connect: Tips have electrodes that are too large to fit monopolar cables and are unusable.
- Root cause tag
- design
- FDA root cause
- Device Design
- Action
- Stryker notified their sales representatives by phone. Stryker sent all consignees a Product Advisory Notice dated November 19, 2007, and verbally notified them of the recall via telephone. A response form with return postage was sent with the notice. The letter requested the hospitals to quarantine and return the product to Stryker.
- Quantity in commerce
- 59 boxes of 6 units (354 total)
- Distribution
- Nationwide Distribution.
- Product codes and lots
- Lot Number: 07297FE2
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