Recall Z-2755-2016 ยท GES Blade, Scalpel
Aspen Surgical Puerto Rico Corp.
Intermediate carton label reads in part as: "Bard-Parker***Stainless Steel Surgical Blades***#12B***QTY 150 (3 x 50)***REF 371712***LOT 0088464." Intended for tissue separation and other procedures that require a sharp surgical blade to puncture or cut.
| Date | Sep 8, 2016 (initiated Jun 27, 2016) |
| Status | Terminated |
| Reason | After receiving a complaint the firm disclosed that Conventional Stainless Steel Surgical Blade catalog number 371712 lot 0088464 was incorrectly identified in the single unit foil pack as 12 instead of 12B. |
| Root cause | Mixed-up of materials/components |
| Action | An "Urgent: Medical Device Correction" letter was sent on June 27, 2016. The letter provided background on the issue, as well as actions to be taken by the user. Customers have the alternative to either keep the product or return it for replacement. A response form was included for customers to complete and return. Customers are to maintain awareness of the incorrect identification prior to use. Questions concerning the correction can be directed to Pedro.Garcia@WelchAllyn.Com. |
| Quantity | 6,000 pieces |
| Distribution | US distribution only. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.