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Manufacturers
Teleflex Creek Dr
Manufacturer Address
Teleflex Creek Dr, 4024 Stirrup Creek Dr, Durham NC 27703-9000
Source
USFDA
10 Events
Recall of Device Recall Bondek Sutures
Recall of Device Recall Bondek Sutures
Recall of Device Recall Bondek Sutures
Recall of Device Recall Bondek Suture
Recall of Device Recall SS wire suture
Recall of Device Recall Monodek Sutures
Recall of Device Recall TEV Sutures
Recall of Device Recall Deklene sutures
Recall of Device Recall NDR Polygly sutures
Recall of Device Recall HUDSON RCI
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10 devices in the database
Device Recall Bondek Sutures
Model / Serial
Bondek¿, TOPS ASSY P/P SLING, Catalog #84414323, Lot #9591.
Product Classification
General and Plastic Surgery Devices
Device Class
2
Implanted device?
Yes
Distribution
Worldwide-, USA including states of CO, FL, IL, IN, MA, and OH, and Countries of Canada, France and Germany
Product Description
Various Sizes of Sterile Polygycolic Acid Synthetic Surgical Suture- Bondek¿, TOPS ASSY P/P SLING, Catalog #84414323
Device Recall Bondek Sutures
Model / Serial
Bondek, BON GN BR 0 GR19 1N7 USAB, Catalog #0500197-2, Lot numbers: 3244075; Bondek, BON GN BR 2-0 GRB 121N7"USAB, Catalog #0520127-2, Lot #2361002; Bondek, BON GNBR 3-0 DR17 1N7"USAB, Catalog #0530177-2, Lot #2401863 & 2498856; Bondek, BON GN BR 2-0 C-2/CST-4336, Catalog #833-136, Lot #2443985 & 3080258; Bondek, BON GN BR 0 TC-43 2N 48, Catalog #833-213, Lot #2528539, & 3163971; Bondek, BON GN BR 2-0 HS 36 1N27, Catalog # B2098G, Lot #2554480.
Product Classification
General and Plastic Surgery Devices
Device Class
2
Implanted device?
Yes
Distribution
Worldwide-, USA including states of CO, FL, IL, IN, MA, and OH, and Countries of Canada, France and Germany
Product Description
Various Sizes of Sterile Polygycolic Acid Synthetic Surgical Suture: Bondek, BON GN BR 0 GR19 1N7 USAB, Catalog #0500197-2, Bondek, BON GN BR 2-0 GRB 121N7"USAB, Catalog #0520127-2, Bondek, BON GNBR 3-0 DR17 1N7"USAB, Catalog #0530177-2, Bondek, BON GN BR 2-0 C-2/CST-4336, Catalog #833-136,Bondek, BON GN BR 0 TC-43 2N 48, Catalog #833-213, Bondek, BON GN BR 2-0 HS 36 1N27, Catalog # B2098G
Device Recall Bondek Sutures
Model / Serial
Bondek, BON+ VI BR 3-0 2X70CM, Catalog # EP0242P, Lot #3328445; Bondek, BON+ VI BR 3-0 HR30+ 1N70CM, Catalog # EP1054XP, Lot #3313774 & 3200044; Bondek, BON+ VI BR 0 HR36+ 1N70CM, Catalog # EP1063XP, Lot #2297080 & 2467234; Bondek, BON+ VI BR 2 HRX27 1N90CM, Catalog # EP1094P, Lot #2486461; Bondek, BON+ VI BR 4-0 HRT17 1N70CM, Catalog # EP1100P, Lot #2351154; Bondek, BON+ VI BR 3-0 HRT17 1N70CM, Catalog #EP1101P, Lot #2351154; Bondek, BON+ VI BR 1 HRX48 1N90CM, Catalog #EP2057P, Lot #2306894 & 3308136; Bondek, BON+ VI BR 2 HRX48 1N90CM, Catalog #EP2058P, Lot #2324039; Bondek, BON+ VI BR 1 HS36 1N70CM, Catalog #EP3000P, Lot #2262121 & 2306894; Bondek, BON+ VI BR 4-0 DS18 1N45CM, Catalog #EP4010P, Lot #2306897; Bondek, BON+ VI BR 3-0 DS18 1N45CM, Catalog #EP4011P, Lot #3211901& 3346174; Bondek, BON+ VI BR 4-0 DS18 1N70CM, Catalog # EP4013P, Lot #2306899 & 2306900; Bondek, BON+ VI BR 3-0 HR26+ 1RN8X45CM, Catalog # EP8029XP, Lot #3335219; Bondek, BON+ VI BR 3-0 6X45CM, Catalog # EP8554P, Lot #3335220.
Product Classification
General and Plastic Surgery Devices
Device Class
2
Implanted device?
Yes
Distribution
Worldwide-, USA including states of CO, FL, IL, IN, MA, and OH, and Countries of Canada, France and Germany
Product Description
Various Sizes of Sterile Polygycolic Acid Synthetic Surgical Suture--Bondek, BON+ VI BR 3-0 2X70CM, Catalog # EP0242P,Bondek, BON+ VI BR 3-0 HR30+ 1N70CM, Catalog # EP1054XP, Bondek, BON+ VI BR 0 HR36+ 1N70CM, Catalog # EP1063XP, Bondek, BON+ VI BR 2 HRX27 1N90CM, Catalog # EP1094P, Bondek, BON+ VI BR 4-0 HRT17 1N70CM, Catalog # EP1100P,Bondek, BON+ VI BR 3-0 HRT17 1N70CM, Catalog #EP1101P, Bondek, BON+ VI BR 1 HRX48 1N90CM, Catalog #EP2057P, Bondek, BON+ VI BR 2 HRX48 1N90CM, Catalog #EP2058P,Bondek, BON+ VI BR 1 HS36 1N70CM, Catalog #EP3000P, Bondek, BON+ VI BR 4-0 DS18 1N45CM, Catalog #EP4010P, Bondek, BON+ VI BR 3-0 DS18 1N45CM, Catalog #EP4011P, Bondek, BON+ VI BR 4-0 DS18 1N70CM, Catalog # EP4013P, Bondek, BON+ VI BR 3-0 HR26+ 1RN8X45CM, Catalog # EP8029XP, Bondek, BON+ VI BR 3-0 6X45CM, Catalog # EP8554P
Device Recall Bondek Suture
Model / Serial
Bondek, BON+ BG BR 1 HRX27 1N70CM, Catalog # EP1082N, Lot #2535750; Bondek, BON+ BG BR 2-0 HR26+ 1RN4X45CM, Catalog # EP8027XN Bondek, BON+ BG BR 0 12X45CM, Catalog # EP8656N, Lot #2297631; Bondek, BON+ BG BR 2 12X45CM, Catalog # EP8658N, Lot #2396240, 2498757 & 2511511.
Product Classification
General and Plastic Surgery Devices
Device Class
2
Implanted device?
Yes
Distribution
Worldwide-, USA including states of CO, FL, IL, IN, MA, and OH, and Countries of Canada, France and Germany
Product Description
Various Sizes of Sterile Polygycolic Acid Synthetic Surgical Sutures -Bondek, BON+ BG BR 1 HRX27 1N70CM, Catalog # EP1082N, Bondek, BON+ BG BR 2-0 HR26+ 1RN4X45CM, Catalog # EP8027XN, Bondek, BON+ BG BR 0 12X45CM, Catalog # EP8656N, Bondek, BON+ BG BR 2 12X45CM, Catalog # EP8658N
Device Recall SS wire suture
Model / Serial
SS Wire, STL MF 7 HSCX48 1N 18 X2, Catalog #29-6567M2; SS Wire, STL MF 6 HSCX48 1N 18 X6, Catalog #29-6619M6, Lot #105821; SS Wire, STL MF 6 K-60 1N 18"X8, Catalog #29-7270M8, Lot #80513; SS Wire, STL MF 5 K-60/ B-60 1N18 X7, Catalog #29-9001M7, Lot #1015798; SS Wire, STL MF 5 K-61 1N 2X30, Catalog # E2-5367M2, Lot #67227; SS Wire, STL MF 5 K-60 1N 6X18, Catalog # E29-5652M6 SS Wire, STL MF 6 K-60 1N 4X18, Catalog # E29-7270M4, Lot #67228; SS Wire, STL MF 5 K-60 1N 45CM, Catalog # E29-7272B, Lot #39238; SS Wire, STL MF 5 K-60 2N 30, Catalog #X-2235, Lot #8727; SS Wire, STL MF 0 KC-6 1N 18, Catalog #X-3399. Lot #72507.
Product Classification
General and Plastic Surgery Devices
Device Class
2
Implanted device?
Yes
Distribution
Worldwide-, USA including states of CO, FL, IL, IN, MA, and OH, and Countries of Canada, France and Germany
Product Description
Various Types, Sterile/Nonsterile Stainless Steel Nonabsorable Surgical Sutures-SS Wire, STL MF 7 HSCX48 1N 18 X2, Catalog #29-6567M2; SS Wire, STL MF 6 HSCX48 1N 18 X6, Catalog #29-6619M6, SS Wire, STL MF 6 K-60 1N 18"X8, Catalog #29-7270M8,SS Wire, STL MF 5 K-60/ B-60 1N18 X7, Catalog #29-9001M7, SS Wire, STL MF 5 K-61 1N 2X30, Catalog # E2-5367M2, SS Wire, STL MF 5 K-60 1N 6X18, Catalog # E29-5652M6, SS Wire, STL MF 6 K-60 1N 4X18, Catalog # E29-7270M4,SS Wire, STL MF 5 K-60 1N 45CM, Catalog # E29-7272B, SS Wire, STL MF 5 K-60 2N 30, Catalog #X-2235, SS Wire, STL MF 0 KC-6 1N 18, Catalog #X-3399.
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