Reported Jun 21, 2017 · Terminated
Sutures. POLYSORB
Medtronic
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic · 60 Middletown Ave · North Haven, CT · 06473-3908
Is this the product you have?
Sutures. POLYSORB
60 of 60 products
| Model / number | Product as published |
|---|---|
| — | POLSORB 0 18 U/D PRECUT 126R, Item Number: L4 |
| — | POLSORB 0 18 VIO PRECUT 226T |
L14 | — |
L404 | POLSORB 0 30 VIO PRECUT 227C |
| — | POLSORB 1 18 VIO PRECUT 122J |
L15 | — |
| — | POLSORB 1 30 VIO PRECUT 224E |
L405 | — |
LL111 | POLSORB 4/0 60" REEL VIO 217T |
L24 | POLYSORB 0 18 UNDYED PRECUT |
CL14MG | POLYSORB 0 18" UNDYED GS-21 DT |
L27 | POLYSORB 0 18" VIOLET PRECUT |
LL104 | POLYSORB 0 60 U/D REEL 203G |
L25 | POLYSORB 1 18" UNDYED PRECUT |
CL11MG | POLYSORB 1 18" VIOLET GS-21 DT |
CL6M | POLYSORB 1 30" VIOLET GS-21 DT |
CL885M | POLYSORB 1 30" VIOLET GS-22 DT |
CL64M | POLYSORB 1 30" VIOLET GS-25 DT |
CLT633M | POLYSORB 2 VL 5 X 30" BGST-29 DT |
CL52MG | POLYSORB 2/0 18" UNDYED GS-10 DT |
- Lot codes and dates
- POLSORB 0 18 U/D PRECUT 126R D4K0211X D4L1163X D5A0876X POLSORB 0 18 VIO PRECUT 226T D4L1165X D5A0247X D5A0248X D5A0546X POLSORB 0 30 VIO PRECUT 227C D4L1545X D5A0757X POLSORB 1 18 VIO PRECUT 122J D4L1161X D5A0096X POLSORB 1 30 VIO PRECUT 224E D5A0875X POLSORB 4/0 60"REEL VIO 217T D4L1509X POLYSORB 0 18 UNDYED PRECUT D4L1164X POLYSORB 0 18" UNDYED GS-21 DT D4L1756X D4L1758X D5A1745X POLYSORB 0 18" VIOLET PRECUT D5A0249X D5A0755X D5A1219X D5A1220X D5A1315X POLYSORB 0 60 U/D REEL 203G D4K1537X D5A1294X POLYSORB 1 18" UNDYED PRECUT D5A0551X POLYSORB 1 18" VIOLET GS-21 DT D4J0442X D4K2262X D4M0073X D5B0260X D5B0263X POLYSORB 1 30" VIOLET GS-21 DT D4L1431X POLYSORB 1 30" VIOLET GS-22 DT D4J0841X D4K0619X D4L0147X D4L0427X D4M0370X POLYSORB 1 30" VIOLET GS-25 DT D4J1987X POLYSORB 2 VL 5 X 30" BGST-29 DT D4K2021X POLYSORB 2/0 18" UNDYED GS-10 DT D4K2361X D4M0071X D5A1862X POLYSORB 2/0 18" UNDYED GS-21 DT D4L1968X D5A0070X D5A0071X D5A0072X D5A1034X D5A1035X D5B0193X POLYSORB 2/0 18" VIOLET V-20 DT D4L1180GX D5A0308GX D5A0528GX D5A1042GX D5B0427GX POLYSORB 2/0 30" VIOLET V-20 DT D4K1263GX POLYSORB 2-0 30" VIOLET V-30 DT D4L1371X POLYSORB 3/0 18" UNDYED V-20 DTPOLYSORB 3/0 18" VIOLET CV-25 DT
D5A0171GXD5A0409GXD5A0962GXD5A1748GXD5A1805GXD5A1869GXD5B0242GXD5B0267GXD5B0539GXD5B0540GX
POLYSORB 3/0 18" VIOLET V-20 DTD4L0058XD4L0108XD4L0637XD4L0638XD4L0639XD4L2006XD4L2010XD4L2201XD4M0267XD4M0362XD5A0170XD5A0172XD5A0307XD5A0479XD5A0529XD5A0963XD5A1041XD5A1401XD5A1422XD5B0149XD5B0266XD5B0844X
POLYSORB 3/0 30" VIOLET V-20 DT D5A0513GX D5A0515GX POLYSORB 3/0 60 U/D REEL 104R D5A1291X POLYSORB 3-0 30" VIOLET CV-25 DT D4K2438X POLYSORB 4/0 18" VIOLET CV-25 DTD4L1177GXD4L1179GXD4L1962GXD4L2077GXD4L2202GXD5A0306GXD5A0480GXD5A1039GX
POLYSORB 4/0 30" VIOLET V-20 DT D4L0759GX POLYSORB* 0 18" VIOLET GS-21 DTD5A0410XD5A1037XD5A1397XD5A1398XD5A1399XD5A1400XD5A1746XD5A1747XD5A1870XD5B0148XD5B0150XD5B0243XD5B0536X
POLYSORB* 0 24" VIOLET PRECUT D4K2023X D4L1547X POLYSORB* 0 30" VIOLET GS-21 REG ATTCH D5A1024X POLYSORB* 0 30" VIOLET GS-22 DT D4K1616X POLYSORB* 0 30" VIOLET PRECUT D4M1190X D5A0228X D5A0549X POLYSORB* 0 5 X 30" UNDYED GS-21 DT D4K1415X D5A1026X D5A1028X POLYSORB* 0 VIOLET 5X30" HGS-20 D-TACH D4L1563X D4M1020X POLYSORB* 0 VIOLET 5X30" HGS-21 D-TACH D4M0368X POLYSORB* 0 VIOLET 60 REEL D4L1866X D5A0869X POLYSORB* 0 VIOLET 98" REELD5A0169XD5A0303XD5A0304XD5A0305XD5A0406XD5A0478XD5A0524XD5A0525XD5A0526XD5A0889XD5A0890XD5A0961XD5A1031XD5A1032XD5A1033XD5A1392XD5A1393XD5A1394XD5A1395XD5A1396XD5A1743XD5A1861XD5B0014XD5B0261XD5B0264XD5B0423XD5B0424X
POLYSORB* 1 18" VIOLET PRE-CUT D4K1272X D4L1740X D4M1189X D4M1224X D5A0756X POLYSORB* 1 30" VIOLET PRECUT D4K2024X D4L1162X D5A0548X POLYSORB* 1 5 X 30" VIOLET HOS-12 DT D4L1159X POLYSORB* 1 VIOLET 30" GS-26 D4L1131X POLYSORB* 1 VIOLET 98" REEL D4J0947X D4L0704X D4L2029X D4L2109X D5A0823X D5A0951X POLYSORB* 2 30" VIOLET GS-25 DT D4K1044X POLYSORB* 2 UNDYED 12X18" PRECUT D4J0736X D4K0212X D5A0402X POLYSORB* 2 VIOLET 12X18" PRECUT D4K2022X D4L1546X POLYSORB* 2 VIOLET 2X36" BGS-29 (2X90CM) D4L0467X POLYSORB* 2 VIOLET 30" GS-26 D4M0542X POLYSORB* 2 VIOLET 5X24" GS-24 D-TACH* ( D4L0692X POLYSORB* 2 VIOLET 6X30" PRE-CUT D5A0098X POLYSORB* 2 VIOLET 98" REEL D4L0640X D4L0641X D4L0642X POLYSORB* 2-0 VIOLET 60 REEL D4L0065X D4L0515X D4L1429X D4L2118X D4M0410X D5A0104X D5A0109X POLYSORB* 2-0 VIOLET 98" REELD4L0689XD4L1166XD4L1677XD4L1867XD4L2107XD4M1187XD5A0723XD5A0724XD5A1298X
POLYSORB* 3-0 VIOLET 60 REEL D4L1170X D4L2106X D5A0110X D5A0771X D5A0811X POLYSORB* 3-0 VIOLET 98" REEL D4K2315X D5A1231X D5A1803X POLYSORB* 4/0 98" VIOLET REEL 110T D4L1169X D4M0237X D5A1288X D5A1297XD4K1392XD4K1612XD4K2139XD4L0279XD4L0822XD4L1005XD4L1399XD4L2111XD4M1186XD5A0102XD5A0105XD5A0106XD5A0107XD5A0112XD5A0113XD5A1233XD5A1290XD5A1339XD5B0302X
- POLSORB 0 18 U/D PRECUT 126R D4K0211X D4L1163X D5A0876X POLSORB 0 18 VIO PRECUT 226T D4L1165X D5A0247X D5A0248X D5A0546X POLSORB 0 30 VIO PRECUT 227C D4L1545X D5A0757X POLSORB 1 18 VIO PRECUT 122J D4L1161X D5A0096X POLSORB 1 30 VIO PRECUT 224E D5A0875X POLSORB 4/0 60"REEL VIO 217T D4L1509X POLYSORB 0 18 UNDYED PRECUT D4L1164X POLYSORB 0 18" UNDYED GS-21 DT D4L1756X D4L1758X D5A1745X POLYSORB 0 18" VIOLET PRECUT D5A0249X D5A0755X D5A1219X D5A1220X D5A1315X POLYSORB 0 60 U/D REEL 203G D4K1537X D5A1294X POLYSORB 1 18" UNDYED PRECUT D5A0551X POLYSORB 1 18" VIOLET GS-21 DT D4J0442X D4K2262X D4M0073X D5B0260X D5B0263X POLYSORB 1 30" VIOLET GS-21 DT D4L1431X POLYSORB 1 30" VIOLET GS-22 DT D4J0841X D4K0619X D4L0147X D4L0427X D4M0370X POLYSORB 1 30" VIOLET GS-25 DT D4J1987X POLYSORB 2 VL 5 X 30" BGST-29 DT D4K2021X POLYSORB 2/0 18" UNDYED GS-10 DT D4K2361X D4M0071X D5A1862X POLYSORB 2/0 18" UNDYED GS-21 DT D4L1968X D5A0070X D5A0071X D5A0072X D5A1034X D5A1035X D5B0193X POLYSORB 2/0 18" VIOLET V-20 DT D4L1180GX D5A0308GX D5A0528GX D5A1042GX D5B0427GX POLYSORB 2/0 30" VIOLET V-20 DT D4K1263GX POLYSORB 2-0 30" VIOLET V-30 DT D4L1371X POLYSORB 3/0 18" UNDYED V-20 DT
- Amount recalled
- 478,465 (total for all products)
This recall covers 8 products
The agency filed one notice per product. You are reading one of them; the other 7 are below.
Where it was sold
Why it was recalled
Potential for an incomplete seal on the inner package, which may result in premature degradation of the suture material.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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