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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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Medium RiskFDA Device

Teleflex Medical: Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use.

Agency Publication Date: May 7, 2014
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Affected Products

Product: Nonabsorbable Surgical Suture, U.S.P., Sterile - Do Not Resterilize, Deknatel. Indicated for use in soft tissue approximation.

Product Code 1154654 - Lot 02K0801212

Lot Numbers:
1154654
02K0801212
Product: Teleflex Medical, Research Triangle Park, NC, Braided Polyester Rx Only, Sterile, Distributed by Boston Scientific, Natick, MA; Tevdek II, Green Braided PTFE Impregnated Polyester Fiber, Nonabsorbable Surgical Suture, USP Sterile, Deknatel; Tevdek II, White Braided PTFE, Impregnated Polyester Fiber, Nonabsorbable Surgical Suture, USP, Sterile, Deknatel; Silky II Polydek White Braided PTFE, Impregnated Polyester Fiber, Nonabsorbable surgical Suture, USP, Sterile, Deknatel; Silky II Polydek, Gree

Product Code 0100019-507 -Lot 02F1301128, Product Code 6-511 - Lot 02M0800561, Product Code 6-559 - Lot 02A0800005, Product Code 69-403 - Lot 02H0802530, Product Code 7-5008M4 - Lot 02C0900466, Product Code 7-518 - Lot 02E1302561, Product Code 7-565 - Lot 02B1100185, Product Code 7-655A - Lot 02C0901963, Product Code 7-655A - Lot 02M0800836, Product Code 7-740 - Lot 02L1000536, Product Code 833-114 - Lot 02A1202112, 02C0902841, 02C0903374, 02D1202794, 02F0902697, 02K1100404, 02L1202369, 02M0802509, Product Code E13-6351 - Lot 02F0902446, Product Code E13-6354 - Lot 02F0902439, Product Code E13-6399 - Lot 02F0902436, Product Code E6-545 Lot 02F0902443, Product Code E7-4578 Lot 02D0901672, Product Code RN6-5106M5 - Lot 02F1003837, Product Code RN7-536M5 - Lot 02A0801205, Product Code TEV100 - Lot 02G1101500, Product Code V-2599 - Lot 02F0802055, 02F0802055, Product Code X-5424 - Lot 02B0900765, Product Code X6-692W - Lot 02C0803135, Product Code X7-655M6A - Lot 02A0900806, 02A0902742, 02C0900446, 02H1003233, Product Code XF7-7011 - Lot 02A0901594

Lot Numbers:
0100019-507
02F1301128
6-511
02M0800561
6-559
02A0800005
69-403
02H0802530
7-5008M4
02C0900466
7-518
02E1302561
7-565
02B1100185
7-655A
02C0901963
7-655A
02M0800836
7-740
02L1000536
833-114
02A1202112
E13-6351
02F0902446
E13-6354
02F0902439
E13-6399
02F0902436
E6-545
02F0902443
E7-4578
02D0901672
RN6-5106M5
02F1003837
RN7-536M5
02A0801205
TEV100
02G1101500
V-2599
02F0802055
X-5424
02B0900765
X6-692W
02C0803135
X7-655M6A
02A0900806
XF7-7011
02A0901594
Product: Teleflex Medical, Research Triangle Park, NC, Polypropylene, Rx Only, Sterile, Distributed by Boston Scientific, Natick, MA; CAPIO Green Braided Coated Polyglycolic Acid Suture, Synthetic Absorbable Surgical Suture SUP, RX Only, Teleflex; Deklene II Polypropylene Blue Monofil, Blue Monofilament Polypropylene Suture, Nonabsorbable Surgical Suture USP, Deknatel; Deklene MAXX, Blue Monofilament Polypropylene suture Nonabsorbable Surgical Suture USP, Deknatel. Indicated for use in soft tissue ap

Product Code 833-123 - Lot 02A0902858, 02D0900775, 02G1003092, 02H1100535, 02H1100536, 02K1102309, Product Code 833-124 - Lot 02A1200503, 02B1101450, 02C0903400, 02D0900010, 02D0900103, 02D1003285, 02D1003286 02F1302321, 02G1000045, 02G1300348, 02G1301122, 02H1100494, 02L0803407, 02L1100009, 02M1002289, 02M1101933, 02F1302322, Product Code 833-213 - Lot 02H1100687, Product Code D-5007K - Lot 02B1002310, 02C1103731, 02F1100069, 02H1102294, Product Code D-5007M4A - Lot 02M0902844, Product Code D-5007M4K - Lot 02C1002252, 02F1100124, Product Code D-7016M4K - Lot 02G1301749, Product Code D-7070K - Lot 02A1103450, 02B1002276, Product Code D-7070M4K - Lot 02C1103707, 02F1301100, 02G1100876, 02G1301739, 02F1101036, 02J1301343, 02K0900010, Product Code D-7076M1K - Lot 02H1103237, Product Code D-7375K - Lot 02A1201015, Product Code D-793M4K - Lot 02L1002488, Product Code ED-6072 - Lot 02C1002218, 02E1002342, 02J0902517, Product Code ED-6276 - Lot 02F0902457, Product Code ED-6896 - Lot 02A0902278, 02B0900089, 02B0901762, 02C0900661, 02C1002207, 02D0900634, 02D1100186, 02E0901921, 02E0902608, 02E1301581, 02H1300608, 02J0900501, 02K0901590, 02K0902406, 02L0900676, 02M0901869, 02G1301755, Product Code ED-852 - Lot 02G1002594, Product Code ED-863 - Lot 02B0902976, 02D0902457, 02M0901348.

Lot Numbers:
833-123
02A0902858
833-124
02A1200503
833-213
02H1100687
D-5007K
02B1002310
D-5007M4A
02M0902844
D-5007M4K
02C1002252
D-7016M4K
02G1301749
D-7070K
02A1103450
D-7070M4K
02C1103707
D-7076M1K
02H1103237
D-7375K
02A1201015
D-793M4K
02L1002488
ED-6072
02C1002218
ED-6276
02F0902457
ED-6896
02A0902278
ED-852
02G1002594
ED-863
02B0902976
Product: Fixt Suture Bonded Plus Violet Braided Polyglycolic Acid Coated Suture, Synthetic Absorbable Surgical Suture, Sterile, Rx Only, Teleflex Medical. Indicated for use in soft tissue approximation.

Product Code BON100 - Lot 02H1302839, 02J1101705, 02D1101137, 02F1103013, Product Code EP4049N - Lot 02A1003137

Lot Numbers:
BON100
02H1302839
EP4049N
02A1003137
Product: Bard Fixt Suture Braided Polyester, Rx Only, Teleflex Medical, Research Triangle Park, NC USA Assembled in Mexico. Indicated for use in soft tissue approximation.

Product Code H5300 - Lot 1450153E13

Lot Numbers:
H5300
1450153E13
Product: Deknatel Teleflex Medical Stainless Steel 2 (metric 5) Monofilament Stainless Steel Suture, Nonabsorbable Surgical Suture, U.S.P. Used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

Product Code X-4981M4 - Lot 02J0800451

Lot Numbers:
X-4981M4
02J0800451
Product: Deknatel Teleflex Medical Silk Black Braided Silk Suture Nonabsorbable Surgical Suture U.S.P. Indicated for use in soft tissue approximation.

Product Code X-6371M5 - Lot 02E0801603

Lot Numbers:
X-6371M5
02E0801603

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 67711
Status: Resolved
Manufacturer: Teleflex Medical
Manufactured In: United States
Units Affected: 7 products (32,271 ea.)

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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 · 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.