Synchro2, 0.014in x 200cm STANDARD Guidewire with Hydrophilic Coating, UPN Product No. M00326410, REF 2641, STERILE: EO
FDA device recall Z-0229-2020 · posted 2019-10-29 · Terminated
Recall details
- Recalling firm
- Stryker Neurovascular
- Reason for recall
- The product labels (pouch and carton) for products contain an incorrect value in millimeters (0.036mm) for the Guidewire Outer Diameter dimension. The inches dimension (0.014in) on the label is correct. The correct values are 0.014in (0.36mm). 0.036mm represents a typographical error.
- Action taken
- On 6/08/18, "Urgent Medical Device Voluntary Customer Communication" were mailed via courier. The firm informed its customers that it has become aware that the product label (pouch and carton) for the affected products contain an incorrect value in millimeters (0.036 mm) for the Guidewire Outer Diameter dimension, but there will be no products being recalled. The Customer Notification Letter instructs customers to read this communication carefully and complete the following actions: 1. Immediately check your inventory. 2. Review the Communication and ensure full understanding of the contents. 3. Circulate this Customer Communication internally to all interested/affected parites. 4. Inform the Recalling Firm if any of the subject devices have been distributed to other organizations. 5. Please provide contact details so that the Recalling Firm can inform the recipients appropriately. 6. Please inform the Recalling Firm of any adverse events concening the use of the subject devices. 7. Return the completed form to your nominated Sales Representative of to NVFieldActions@stryker.com. 8. The Recalling Firm is requesting that customers respond to the Customer Communication within 7 calendar days for the date of receipt and a target date for completion of this action is 30 June 2018.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- DQX
- Quantity affected
- 21971
- Distribution
- Worldwide distributions- U.S. Nationwide including the states of AL, AZ, AR, CA, CO, CT, DC, DE, FL, GA, GU, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC,
- Date initiated
- 2018-06-08
- Date posted
- 2019-10-29
- Date terminated
- 2021-04-28
- Location
- Fremont, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Synchro2 Support Guidewire (K190843) | Stryker | 2019-05-01 |