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Class 2 Device Recall Surgilon Braided Nylon sutures |
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Date Initiated by Firm |
December 21, 2023 |
Date Posted |
January 29, 2024 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-0844-2024 |
Recall Event ID |
93768 |
510(K)Number |
K981582
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Product Classification |
Suture, nonabsorbable, synthetic, polyamide - Product Code GAR
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Product |
Surgilon Braided Nylon sutures:
88861919-31 SURGILON* 4-0 BLK 7X75CMPCT 88861919-41 SURGILON* 3-0 BLK 7X75CMPCT 88861919-51 SURGILON* 2-0 BLK 7X75CMPCT 88861919-71 SURGILON* 1 BLK 7X75CM PCT
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Code Information |
Model 88861919-31 SURGILON* 4-0 BLK 7X75CMPCT
UDI-DI 10884521071728, 20884521071725
Lots
D1L1929RY
D2B2243RY
Model 88861919-41 SURGILON* 3-0 BLK 7X75CMPCT
UDI-DI 10884521071742, 20884521071749
Lot
D2B0176RY
Model 88861919-51 SURGILON* 2-0 BLK 7X75CMPCT
UDI-DI 10884521071766
Lots
D2D2437RY
UDI-DI 20884521071763
Lots
D2D2437RY
D2E0905RY
D2E0916RY
Model 88861919-71 SURGILON* 1 BLK 7X75CM PCT
UDI-DI 20884521071794
Lots
D1M0640RY
D1M1494RY
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Recalling Firm/ Manufacturer |
Covidien LP 15 Hampshire St Mansfield MA 02048-1113
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For Additional Information Contact |
Technical Service 800-962-9888 Ext. 2
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Manufacturer Reason for Recall |
Specific lots of sutures were sterilized with gamma doses that exceeded the range approved. The extra gamma levels may decrease the strength of the sutures over time, which could result in harms such as wound dehiscence and hemorrhage/blood loss/ bleeding at a critical level.
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FDA Determined Cause 2 |
Process control |
Action |
On December 21, the firm notified affected consignees via URGENT MEDICAL DEVICE RECALL letters.
Customers were instructed to identify, quarantine, and return all unused, non-expired affected sutures to Medtronic. Please contact rs.covidienfeedbackcustomerservice@medtronic.com for the Return Good Authorization (RGA). Customers will receive credit for returned affected product. If purchased from a distributor, please contact your distributor directly to arrange for the return of product back to your distributor.
Pass on the recall notice to all those who need to be aware within your organization, or to any organization where the affected sutures have been transferred or distributed.
If you have questions regarding this recall, please call Medtronic Quality Assurance at 800-255-6774 option 1, then option 1
***Updated 4/1/2024***
Firm identified additional models and lots affected by the gamma radiation issue and sent additional notification to customers on January 25, 2024. |
Quantity in Commerce |
46,812 US; 68,976 OUS |
Distribution |
Worldwide US Nationwide distribution including in the states of AL, AZ, CA, FL, GA, HI, IA, IL, IN, MD, MI, MN, MO, MS, NC, NE, NJ, NV, NY, OH, OK, OR, PA, PR, TN, TX, VA, WA, WV and the countries of Australia, Bahrain, Belgium, Bulgaria, Canary Islands, China, Cyprus, Czech Republic, Finland, France, Germany, Greece, Hong Kong, Hungary, Italy, Japan, Korea, Republic Of Kosovo, Mongolia, Netherlands, New Zealand, Panama, Poland, Portugal, Puerto Rico, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, United Kingdom.
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Total Product Life Cycle |
TPLC Device Report
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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.
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510(K) Database |
510(K)s with Product Code = GAR and Original Applicant = DAVIS & GECK, INC.
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