380851 | see letter

MD: Indwelling urethral drainage catheter

Medical Device Safety Alert: Coloplast Catheter Valve

P/N: 380851, L/N: 2191186 / 2253015 / 2253016 / 2273526 / 2273527 / 2273528 / 2291648/ 2318719 / 2319433 / 2319434 / 2338951 / 2338952 / 2355658 / 2424634 / 2442118 / 2457651 / 2497253 / 2497254 / 2523235 / 2565208 / 2635118 / 2646228 / 2646231 / 2662994 / 2662996 / 2696297 / 2696299 / 2701396 / 2701398 / 2708828 / 2708831 / 2724652 / 2730835 / 2762157 / 2769329 / 2777880 / 2793517 / 2799062 / 2800400 / 2812339 / 2819240 / 2823831 / 2825445 / 2843647 / 2860143 / 2873090 / 2887949 / 2918547 / 2918548

Catheter valve, Indwelling urethral drainage catheter

Lot Numbers: 3880261, 3880268, 3932929, 3932933, 3940329, 3940332, 3949825, 3949828, 3968997, 3969002, 3997492, 3997778, 3997782, 4006822, 4019572, 4019574, 4047072, 4047075, 4056422, 4056423, 4056428, 4073930, 4073934, 4092990, 4092991, 4100228.

Gastroenterology-Urology Devices

1

No

Nationwide Distribution including Puerto Rico and the states of AL, AZ, CA, CO, FL, GA, ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS,MO,NE,NH, NJ, NY, NC, ND, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, and WV.

Coloplast Conveen Urine Collection Leg Bag, Product Numbers 5170, 5171, and 5174. || Urine Collection Bag.

Model: PR3001, PR3002, PR3003, PR3004, PR3005, Affected: All lots

Model: Catalogue: 29123, Affected: All lot numbers

Model: All models, Affected: All lots

Coloplast Testicular Implant and Vaginal Stent. Priority 1 – For Immediate Action

Coloplast urogynaecological surgical meshAris KitARTG Number: 157074Altis SystemARTG Number: 190173Restorelle YRestorelle Y-XLRestorelle LRestorelle MRestorelle XLRestorelle DirectFix PosteriorRestorelle DirectFix AnteriorARTG Number: 190172

medical_device

Connectable Pusher CH/FR 4.8/75cm REF YN2813 included in the following kits: VORTEK Double Loop Ureteral Stent Open/Open With Connectable Pusher and VORTEK Hydro- Coated Double Loop Ureteral Stents

REF: YN2867 included in the following kits: see FSN | see FSN

MD: Ureteral stent-placement set

Conveen catheter valve, Simpla catheter valve, Catheter

Model Catalog: 0506201404 (Lot serial: 576108)

CONVEEN URININE BAG 1500 ML90 CM TUBE

Model Catalog: UT1002 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: UT 8140 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: UT 7030 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: UT 7010 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: UT1002 (Lot serial: >10 CONTACT MFR. OR IMP.); Model Catalog: UT1001 (Lot serial: >10 CONTACT MFR. OR IMP.); Model Catalog: UT 8140 (Lot serial: >10 CONTACT MFR. OR IMP.); Model Catalog: UT 7030 (Lot serial: >10 CONTACT MFR. OR IMP.); Model Catalog: UT 7010 (Lot serial: >10 CONTACT MFR. OR IMP.); Model Catalog: UT1001 (Lot serial: > 10 lot numbers contact mfg)

CYSTO-CARE UROLOGICAL PROCEDURE TRAYS

Injections / Infusions / Transfusions / Dialysis

CYSTODRAIN Supra-pubic drainage kit with silicone balloon catheter