Stryker Scope Warmer, disposable. Endoscopic accessory composed of polyvinyl Chloride (PVC) and Sodium Acetate, Model Nu
FDA device recall Z-2622-2010 · posted 2010-09-29 · Terminated
Recall details
- Recalling firm
- Stryker Endoscopy
- Reason for recall
- Outer packaging seals have inconsistencies that have resulted in compromised seals and may result in compromised sterility.
- Action taken
- Stryker issued an Urgent Device Removal letter, dated June 21, 2010, to customers which identified the affected product, the sterility issue, and the actions to be taken by the customer. Customers were instructed to identify and quarantine any affected product in their inventory, and contact Stryker Customer Service at 800 624-4422 and request an RMA#. The RMA# is to be written on the outside of the package used to return products, using an enclosed pre-paid shipping label. All cusotmers are to complete and sign an enclosed "acknowledgement of receipt" and fax to (408) 754-8278. Stryker can be contacted at 800-624-4422.
- Root cause
- Process control
- Status
- Terminated
- Product code
- GCJ
- Quantity affected
- 191855 units
- Distribution
- Worldwide Distribution: USA, Including the states of AK, AL, AR, CA, CO,CT, DE, DC, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MS, MO, MT, NE, NJ, NM, NH, NV, NC, ND, OH, OK, OR, PA, RI,
- Date initiated
- 2010-06-21
- Date posted
- 2010-09-29
- Date terminated
- 2010-12-16
- Location
- San Jose, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STRYKER SCOPE WARMER (K053311) | Stryker Endoscopy | 2006-01-27 |