Recall Z-2541-2017— Medtronic

Class II FDA medical device recall by Medtronic, initiated 2017-05-03, terminated 2019-07-18. It names one FDA 510(k) clearance: K963253. Product: Sutures. POLYSORB: POLSORB 0 18 U/D PRECUT 126R, Item Number: L4; POLSORB 0 18 VIO PRECUT 226T; Item Number: L14; POLSORB 0 30 VIO PRECUT 227C, Item Number: L404; POLSORB 1 18 VIO PRECUT 122J; Item Number: L15; POLSORB 1 30 VIO PRECUT 224E; Item Number: L405; POLSORB 4/0 60" REEL VIO 217T, Item Number: LL111; POLYSORB 0 18 UNDYED PRECUT, Item Number: L24; POLYSORB 0 18" UNDYED GS-21 DT, Item Number: CL14MG; POLYSORB 0 18" VIOLET PRECUT, Item Number: L27; POLYSORB 0 60 U/D REEL 203G, Item Number: LL104; POLYSORB 1 18" UNDYED PRECUT, Item Number: L25; POLYSORB 1 18" VIOLET GS-21 DT, Item Number: CL11MG; POLYSORB 1 30" VIOLET GS-21 DT, Item Number: CL6M; POLYSORB 1 30" VIOLET GS-22 DT, Item Number: CL885M; POLYSORB 1 30" VIOLET GS-25 DT, Item Number: CL64M; POLYSORB 2 VL 5 X 30" BGST-29 DT, Item Number: CLT633M; POLYSORB 2/0 18" UNDYED GS-10 DT, Item Number: CL52MG; POLYSORB 2/0 18" UNDYED GS-21 DT, Item Number: CL13MG; POLYSORB 2/0 18" VIOLET V-20 DT, Item Number: GL62MG; POLYSORB 2/0 30" VIOLET V-20 DT, Item Number: GL66M; POLYSORB 2-0 30" VIOLET V-30 DT, Item Number: GL223M; POLYSORB 3/0 18" UNDYED V-20 DT, Item Number: GL69MG; POLYSORB 3/0 18" VIOLET CV-25 DT, Item Number: GL33MG and GLJ50M; POLYSORB 3/0 18" VIOLET V-20 DT, Item Number: GL63MG; POLYSORB 3/0 30" VIOLET V-20 DT, Item Number: GL67M; POLYSORB 3/0 60 U/D REEL 104R, Item Number: LL102; POLYSORB 3-0 30" VIOLET CV-25 DT, Item Number: GL182M; POLYSORB 4/0 18" VIOLET CV-25 DT, Item Number: GL34MG; POLYSORB 4/0 30" VIOLET V-20 DT, Item Number: GL68M; POLYSORB* 0 18" VIOLET GS-21 DT, Item Number: CL10MG; POLYSORB* 0 24" VIOLET PRECUT, Item Number: L34; POLYSORB* 0 30" VIOLET GS-21 REG ATTCH, Item Number: 3CL812; POLYSORB* 0 30" VIOLET GS-22 DT, Item Number: CL886M; POLYSORB* 0 30" VIOLET PRECUT, Item Number: L40; POLYSORB* 0 5 X 30" UNDYED GS-21 DT, Item Number: CL2M; POLYSORB* 0 VIOLET 5X30" HGS-20 D-TACH, Item Number: CL997MG; POLYSORB* 0 VIOLET 5X30" HGS-21 D-TACH, Item Number: CL71M; POLYSORB* 0 VIOLET 60 REEL, Item Number: LL114; POLYSORB* 0 VIOLET 98" REEL, Item Number: LL224; POLYSORB* 1 18" VIOLET PRE-CUT, Item Number: L35; POLYSORB* 1 30" VIOLET PRECUT, Item Number: L41; POLYSORB* 1 5 X 30" VIOLET HOS-12 DT, Item Number: CL97MG; POLYSORB* 1 VIOLET 30" GS-26, Item Number: CL60M; POLYSORB* 1 VIOLET 98" REEL, Item Number: LL225; POLYSORB* 2 30" VIOLET GS-25 DT, Item Number: CL665M; POLYSORB* 2 UNDYED 12X18" PRECUT, Item Number: L26; POLYSORB* 2 VIOLET 12X18" PRECUT, Item Number: L28; POLYSORB* 2 VIOLET 2X36" BGS-29 (2X90CM), Item Number: 2CL852; POLYSORB* 2 VIOLET 30" GS-26, Item Number: CL659M; POLYSORB* 2 VIOLET 5X24" GS-24 D-TACH*, Item Number: CL622M; POLYSORB* 2 VIOLET 6X30" PRE-CUT, Item Number: L42; POLYSORB* 2 VIOLET 98" REEL, Item Number: LL226; POLYSORB* 2-0 VIOLET 60 REEL, Item Number: LL113; POLYSORB* 2-0 VIOLET 98" REEL, Item Number: LL223; POLYSORB* 3-0 VIOLET 60 REEL, Item Number: LL112; POLYSORB* 3-0 VIOLET 98" REEL, Item Number: LL222; POLYSORB* 4/0 98" VIOLET REEL 110T, Item Number: LL221. Reason: Potential for an incomplete seal on the inner package, which may result in premature degradation of the suture material..

Recalling firm

Medtronic

Classification

Class II

Status

Terminated

Initiated

2017-05-03

Terminated

2019-07-18

Firm location

North Haven, CT, United States

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