Inflow/Outflow Cannula; Qty: 1; distributed by Stryker Endoscopy, 5900 Optical Court, San Jose, CA 95138 The inflow/outf
FDA device recall Z-1927-2011 · posted 2011-04-08 · Terminated
Recall details
- Recalling firm
- Stryker Endoscopy
- Reason for recall
- Insufficient cleaning instruction were included for the Inflow/outflow Cannula in the user manual.
- Action taken
- The firm, Stryker, issued an "URGENT: DEVICE CORRECTION" memo dated March 8, 2011 to all customers. The memo described the product, problem and actions to be taken. The customers were instructed to discard any old Instructions for Use (1000-400-816 rev. A or B) for their Inflow/Outflow Cannual; download the new IFU (1000-400-816 rev. C) from the URL link: http://stryker.com/InflowOutflowCannual; ensure they follow the new cleaning instructions provided in the IFU and complete and return the enclosed "acknowledgement of receipt" form and fax to (408) 754-8378 or scan in and email to cannula@stryker.com. Stryker stated in the memo that "It is important to send the self addressed confirmation forms back to Stryker RAQA". If you have any questions regarding this letter, please contact us by phone at 1-800-624-4422 or via email at cannula@stryker.com.
- Root cause
- Other
- Status
- Terminated
- Product code
- HRX
- Quantity affected
- 2618 devices
- Distribution
- Worldwide distribution: USA including states of: AL, ALASKA, AK, AR, CA, CO, CT, DC, DE, FL, GA, ID IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NH, NJ, NM, NV, NY, NC, ND, OH, OK, OR,
- Date initiated
- 2011-03-07
- Date posted
- 2011-04-08
- Date terminated
- 2011-10-04
- Location
- San Jose, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ARTHROSCOPE ACCESSORIES (K944210) | Stryker Endoscopy | 1995-02-14 |