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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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High RiskFDA Device
Medical Devices/Surgical Equipment

Covidien LP: Various Surgical Sutures Recalled for Reduced Strength and Injury Risk

Agency Publication Date: January 29, 2024
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Summary

Covidien LP is recalling approximately 93,624 units of various surgical sutures, including Surgilon, Sofsilk, Ti-Cron, Monosof, and Steel varieties, because they were sterilized with excessive radiation. This manufacturing defect can cause the sutures to lose their strength over time, which may lead to serious medical complications like wounds reopening or severe bleeding. Consumers who have these products in their medical inventory should immediately check for the affected model and lot numbers and contact their healthcare provider or the manufacturer for instructions.

Risk

The excessive sterilization doses can cause the suture material to degrade and weaken. If these sutures fail after a procedure, it could result in wound dehiscence (reopening of a surgical incision) or life-threatening hemorrhage and blood loss.

What You Should Do

  1. Identify if you have any affected Surgilon, Sofsilk, Ti-Cron, Monosof, or Stainless Steel sutures by checking the model and lot numbers on the product packaging.
  2. For Surgilon Braided Nylon sutures, check for lots D1L1929RY, D2B2243RY, D2B0176RY, D2D2437RY, D2E0905RY, D2E0916RY, D1M0640RY, and D1M1494RY.
  3. For Sofsilk Braided Silk sutures, check for extensive lot lists including D1L1576RY, D2B1216RY, D2D0612RY, D2B0728RY, D2D0972RY, D2E2396RY, D2D0957RY, D2D0968RY, D2D0971RY, D2D0984RY, D2D0985RY, D2E0900RY, D2E0902RY, D2E0674RY, D2D1871RY, D2E0901RY, D2D0980RY, D2F2101RY, D2D1872RY, D2D2120RY, D2D1991RY, D2E0907RY, D2E2685RY, D2D2436RY, D2E0587RY, D2E0676RY, D2B2638RY, D2D0961RY, D2B1535RY, D2D0254RY, D2D1576RY, D2E1431RY, D2C0576RY, D2J0691RY, D1L3318FRY, D2E2348RY, D2B2217RY, D2D0262RY, D2B2878RY, D2E2680RY, D2E2769RY, D2A1585RY, D1M1020RY, D2D2348RY, D2E1492RY, D2E1375RY, D2E1488RY, D2C1916RY, D2E1470RY, D2E1495RY, D2E1496RY, D2E1472RY, D2C1479RY, D2E2772RY, D1M0153RY, D2A1677RY, D1M0141FRY, D2E1491RY, D1M0173RY, D1M0635RY, D2E1210RY, D1M1837RY, D2B1783RY, D2B2181FRY, D2C1987FRY, D1M2531FRY, D1K1916FRY, D2G0795FRY, and D2E1482RY.
  4. For Ti-Cron, Monosof, and Steel sutures, verify lot numbers D1M2840RY, D2G1007RY, D2C1802RY, D2C3250FRY, D2C2450RY, D1K0110RY, D2C0774RY, D2G1004RY, D2A0451RY, D2G1307RY, D2F2152RY, D2D2188RY, D2A0862RY, D2C1333FRY, D2H1541FRY, and D3B1366RY.
  5. If you have affected sutures, stop using them immediately and quarantine the products to prevent use in surgical procedures.
  6. Contact your healthcare provider or Covidien LP (Medtronic) directly for specific instructions on returning the product and receiving a potential refund or replacement.
  7. For more information, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Quarantine and return product

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Surgilon Braided Nylon sutures
Model / REF:
88861919-31
88861919-41
88861919-51
88861919-71
UPC Codes:
10884521071728
20884521071725
10884521071742
20884521071749
10884521071766
20884521071763
20884521071794
Lot Numbers:
D1L1929RY
D2B2243RY
D2B0176RY
D2D2437RY
D2E0905RY
D2E0916RY
D1M0640RY
D1M1494RY
Product: Sofsilk Braided Silk sutures
Model / REF:
CS-211
GS-831
S-176
S-182
S-184
S-185
S-245
S-246
S-2782K
S-303
S-304
S-305
S-316
S-317
S-605
S-606
S606-12
S-610
CS-792
S-1172
S-1735
S-1750K
S-1768K
S-1789K
S-187
S-243
S-2780K
S-282
S-318
SS-1694G
S-608
VS872
VS872-2
SS-5641
SS-5649G
SS-645
SS-675
SS-681
VS-872
XX-5280
UPC Codes:
20884521083629
20884521085203
20884521085746
20884521085944
20884521085968
20884521085975
10884521086197
20884521086194
20884521086200
20884521086422
20884521086460
20884521086477
20884521086484
20884521086491
20884521086514
20884521086620
10884521086630
20884521086637
10884521637887
20884521086675
20884521758121
20884521757971
20884521084756
20884521085470
20884521085630
20884521085739
20884521085784
20884521085876
20884521085982
20884521086170
10884521086203
20884521086408
20884521086453
20884521086538
20884521176406
20884521086668
20884521090184
20884521758060
20884521086774
20884521086804
20884521087580
20884521087726
20884521087924
20884521106045
Lot Numbers (69):
D1L1576RY
D2B1216RY
D2D0612RY
D2B0728RY
D2D0972RY
D2E2396RY
D2D0957RY
D2D0968RY
D2D0971RY
D2D0984RY
D2D0985RY
D2E0900RY
D2E0902RY
D2E0674RY
D2D1871RY
D2E0901RY
D2D0980RY
D2F2101RY
D2D1872RY
D2D2120RY
D2D1991RY
D2E0907RY
D2E2685RY
D2D2436RY
D2E0587RY
D2E0676RY
D2B2638RY
D2D0961RY
D2B1535RY
D2D0254RY
D2D1576RY
D2E1431RY
D2C0576RY
D2J0691RY
D1L3318FRY
D2E2348RY
D2B2217RY
D2D0262RY
D2B2878RY
D2E2680RY
D2E2769RY
D2A1585RY
D1M1020RY
D2D2348RY
D2E1492RY
D2E1375RY
D2E1488RY
D2C1916RY
D2E1470RY
D2E1495RY
Product: Ti-Cron Coated Braided Polyester Sutures
Model / REF:
3087-31
3226-31
88863026-71
88863070-51
88863087-31
88863092-71
88863147-83
88863185-41
88863186-31
88863226-31
88863226-41
88863229-31
88863271-31
88863309-71
UPC Codes:
10884521632271
10884521632547
20884521059129
20884521059570
10884521059832
20884521059990
10884521060340
20884521061191
10884521061279
20884521061276
20884521061634
20884521061641
20884521061689
10884521062177
20884521062174
20884521062488
Lot Numbers:
D1M2840RY
D2G1007RY
D2C1802RY
D2C3250FRY
D2C2450RY
D1K0110RY
D2C0774RY
D2G1004RY
D2A0451RY
D2G1307RY
D2F2152RY
D2D2188RY
Product: Monosof Monofilament Nylon Sutures
Model / REF:
N-63
SN-3695
UPC Codes:
20884521076607
20884521077994
Lot Numbers:
D2A0862RY
D2C1333FRY
D2H1541FRY
Product: Steel Monofilament Stainless Steel Sutures
Model / REF:
88862224-49
UPC Codes:
20884521102351
Lot Numbers:
D3B1366RY

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93768
Status: Active
Manufacturer: Covidien LP
Sold By: Hospital supply distributors; Medical supply retailers
Manufactured In: United States
Units Affected: 2 products (46,812 US; 68,976 OUS)
Distributed To: Alabama, Arizona, California, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Tennessee, Texas, Virginia, Washington, West Virginia
Agency Last Updated: April 2, 2024

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.