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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic

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  Class 2 Device Recall Medtronic see related information
Date Initiated by Firm December 02, 2022
Date Posted February 25, 2023
Recall Status1 Open3, Classified
Recall Number Z-1175-2023
Recall Event ID 91324
510(K)Number K990952  
Product Classification Suture, nonabsorbable, synthetic, polyethylene - Product Code GAT
Product Novafil Monofilament Polybutester Suture
Product Description:
8886 4002-41 NOVAFIL 3-0 BLU 90CM C14
8886 4400-13 NOVAFIL 6-0 BLU 45CM SBE2
8886 4400-23 NOVAFIL 5-0 BLU 45CM SBE2
8886 440123 NOVAFIL 5-0 BLU 45CM SBE3
8886 4402-33 NOVAFIL 4-0 BLU 45CM SBE4
8886 4403-33 NOVAFIL 4-0 BLU 45CM SBE6
8886 4410-13 NOVAFIL 6-0 BLU 45CM P10
8886 4410-03 NOVAFIL 7-0 BLU 45CM P10
8886 4422-43 NOVAFIL 3-0 BLU 45CM C14
8886 4424-51 NOVAFIL 2-0 BLU 75CM C16
8886 4450-41 NOVAFIL 3-0 BLU 75CM V26
8886 4452-51 NOVAFIL 2-0 BLU 75CM V20
8886 4459-61 NOVAFIL 0 BLU 75CM GS22
8886 4470-81 NOVAFIL* 2 BLU 150CM GS26
8886 4582-53 NOVAFIL* 2-0 BLU 75CM P14
SPB-1213G NOVAFIL* 6-0 BLU 45CM P13X12
SPB-1233G NOVAFIL* 4-0 BLU 45CM P13X12
SPB-1623G NOVAFIL* 5-0 BLU 45CM P12X12
SPB-5142G NOVAFIL* 5-0 BLU 45CM P11X12
SPB-5143G NOVAFIL* 4-0 BLU 45CM P11X12
SUT SPB-5223G NOVAFIL 5-0 BLU 45CM P13
SPB-5433G NOVAFIL* 4-0 CLR 45CM P24X12
SPB-5633G NOVAFIL* 4-0 BLU 45CM P12X12
Code Information GTIN 20884521100821, 20884521100098, 10884521100091, 10884521100299, 20884521100296, 20884521099910, 20884521100814, 20884521100791, 20884521100593, 20884521099965, 20884521099477, 20884521100760, 20884521118345, 10884521118348, 20884521099682, 20884521118406, 20884521099699, 20884521100838, 20884521099699, 20884521118390, 10884521118393, 20884521100890, 10884521100893, 20884521099569, 20884521100692, 20884521100074, 20884521099583, 20884521100876, 20884521100777. Model # Lot #: 8886400241 D1G1762FY, 8886440013 D2A0461Y, 8886440023 D1M0797Y, 8886440123 D1L3389Y, 8886440233 D2A0529Y, 8886440333 D2C0582Y, 8886441003 D1M1007FY, D1M2364FY 8886441013 D1M1007FY D1M2364FY, 8886441003 D1M0369FY D1M0796FY, 8886442243 D1D2485FY, 8886442451 D1E1240FY, 8886445041 D2B2109Y, 8886445251 D1D0295Y, D1E0843Y, 8886445961 D1D0529Y, 8886447081 D1D3190Y, 8886458253 D2B1686FY, SPB1213G D1L0169FY, D2B0773FY D2C0769FY, SPB1233G D2E0961FY, SPB1623G D1D2709FY, SPB5142G D1B2811FY, SPB5143G D1D2674FY, SPB5223G D1M1024FY, SPB5433G D2C1970FY, SPB5633G D2A0500FY, SPB-5223G D1M1024FY
Recalling Firm/
Manufacturer		 Covidien, LP
60 Middletown Ave
North Haven CT 06473-3908
For Additional Information Contact Medtronic Customer Service
800-962-9888
Manufacturer Reason
for Recall		 Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact
FDA Determined
Cause 2		 Packaging process control
Action Medtronic issued an "URGENT: MEDICAL DEVICE RECALL" letter to US consignees on 01-Dec-2022 via UPS 2-day delivery. OUS countries, notifications are handled via a regionally approved method. Letter states reason for recall, health risk and actions to take: Actions: " Identify and quarantine all unused and non-expired affected non-absorbable sutures. " Please note the affected product may be located within Custom Suture Packs. Please reference Custom Suture Packs to identify affected product. " Please complete the enclosed Customer Confirmation Form (even if your account no longer has affected product on hand) and email to rs.gmbfcamitg@medtronic.com.> " Return all unused and non-expired affected product in your inventory to Medtronic as indicated in the Shipping and Return Instructions below. " Pass on this notice to all those who need to be aware within your organization or to any organization where the potentially affected product has been transferred or distributed. Shipping and Return Instructions: " Product purchased directly from Medtronic please contact rs.covidienfeedbackcustomerservice@medtronic.com for Return Good Authorization (RGA). Your local Medtronic Representative can assist you as necessary in initiating the return of this product. " Credit or Replacement for the returned affected product will be issued based on the RGA number. " Return all unused and non-expired affected product(s) in your inventory to: Medtronic, Attn: Field Returns Dept. 195 McDermott Road, North Haven, CT 06473 USA. " If purchased from a distributor, contact your distributor directly to arrange for the return of the product back to your distributor. If you have any questions regarding this communication, please contact your Medtronic Representative or Customer Service at 800-962-9888.
Quantity in Commerce 48492 units
Distribution US Nationwide Distribution and OUS Foreign distribution to countries of: Albania Argentina Armenia Australia Austria Azerbaijan Belarus Belgium Bosnia And Herzegovina Brazil Bulgaria Cambodia Cameroon Canada Canary Islands Chile China Colombia Croatia Czech Republic Denmark Egypt Finland France Georgia Germany Ghana Greece Hong Kong Hungary India Indonesia Iran Iraq Ireland Israel Italy JAPAN Jordan Kazakhstan Kenya Korea, Republic Of Kosovo Kuwait Latvia Lebanon Lithuania Macao Malaysia Malta Mauritius Mexico Moldova, Republic Of Morocco Myanmar Namibia Netherlands New Zealand North Macedonia Norway Pakistan Panama Paraguay Philippines Poland Portugal Reunion Romania Russian Federation Saudi Arabia Serbia Singapore Slovakia Slovenia South Africa Spain Sweden Switzerland Syrian Arab Republic Taiwan Thailand Tunisia Turkey Uganda Ukraine United Arab Emirates United Kingdom Uruguay Uzbekistan Viet Nam Zimbabwe
Total Product Life Cycle TPLC 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = GAT and Original Applicant = UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
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