Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall BardParker

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall BardParkersee related information
Date Initiated by FirmJune 27, 2016
Date PostedSeptember 08, 2016
Recall Status1 Terminated 3 on May 15, 2017
Recall NumberZ-2755-2016
Recall Event ID 74584
Product Classification Blade, scalpel - Product Code GES
ProductIntermediate 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.
Code Information LOT 0088464
FEI Number 2649798
Recalling Firm/
Manufacturer		 Aspen Surgical Puerto Rico Corp.
Rd 183 Km 20.3
Las Piedras PR 00771
For Additional Information ContactPedro Garcia
787-733-4046 Ext. 501
Manufacturer Reason
for Recall		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.
FDA Determined
Cause 2		Mixed-up of materials/components
ActionAn "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 in Commerce6,000 pieces
DistributionUS distribution only.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
-
-