Sterilmed Inc

Orthopedic Devices

1

No

AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, MA, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, WA, WI, and WV OUS: CANADA

Reamers || Model #'s: || HAL5091-144 and || ZIMS5979-95-41 || An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery.

Orthopedic Devices

1

No

AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, MA, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, WA, WI, and WV OUS: CANADA

Taps || Model #'s: || SYN311.15 || SYN311.190 || SYN311.39 and || SYN311.32 || An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery.

Gastroenterology-Urology Devices

1

No

AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, MA, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, WA, WI, and WV OUS: CANADA

Biopsy Forceps, Cold || Model #'s: || BAR000386 || BAR000388 || MIC1012 || MIC1331 || MIC1333 || MIC1337 || MIC1536 || MIC1589 || MIC1597 || MIC1598 and || MIC1599 || The Reprocessed Cold Biopsy Forceps are intended to be used during endoscopic procedures of the gastrointestinal tract to collect tissue samples for histologic examination.

General and Plastic Surgery Devices

1

No

AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, MA, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, WA, WI, and WV OUS: CANADA

Open & Unused Items - This refers to a sterilization service provided by by SterilMed, Inc. (devices were not reprocessed) for Class 1 and Class 2 devices that were opened, most likely in O. R. suites, in which for whatever reason the physician elected to select a different type of device, different size of device, or maybe elected to not use the device at all in a procedure. This is not a process regulated by FDA, but is included in the recall process as product would still be considered misbranded and or represent a potential risk to patients. || Model #'s: || ABB6543-01 || ABB6544-01 || ACM23116 || ACR800-499 || ACU014719 || ALL2N2704X || ALLASC1201 || ALLF-5501 || ALLSU130-404E || ARTAR-6530 || ARTAR-6540 || ARTAR-6560 || ARTAR-6562 || ARTAR-6564 || ARTAR-6570 || AUT054887 || AUT059035 || AUT059037 || AUT174001 || AUT8886803712 || AUTGIA6025S || BAL60417 || BAR0043620 || BAR0070740 || BAR0601110 || BAR072231 || BARBRD100R || BAX2C4005 || BER610 || BIO418200 || BIO631031 || BOUTC001NSKA || CARASU1510 || COD26-1221 || CON130309 || CON130321 || CON134006 || CON1412 || CON29410 || CON29415H || CON29496 || CON60-6085-100 || CON8535 || CON9413 || CON9448 || COO081012 || COO081014 || COOCTI-512N || COOTD-1 || COOZSI1151 || DAV0035280 || DAV0043650 || DEN50-7000 || DEN50-7500 || DER28-0211 || DLP10012 || EDWDSAFE61 || EDWFEMII016A || ETH10BB || ETH2189 || ETH2211 || ETH5BB || ETH6TB45 || ETHBTD05 || ETHPMW35 || ETHPRW35 || ETHPXW35 || ETHUV120 || FUT4549 || GUIOM-9000S || GUIXP-4000 || GYR240060 || GYR240072 || GYR70138000 || GYR7013-8100 || GYR70140257 || JOH2214 || KEN31140240 || KEN31140562 || KEN8884720221 || KEN8888505172 || KIM111 || KIM228 || kim279 || KIM311 || KIM330 || KIM345 || KIM70321 || KIM79043 || KIM79870 || KIM79878 || KIM888 || KIM89601 || KIM95111 || KIM95521 || KIR10-4000 || KIR10-4001 || KIR14-3000 || KRO6003 || LIN9718 || LINESA-5333 || LINESA-5339 || MECEPT03 || MED05897/JP2311 || MED10001S/JP10001 || MED11348/DYNJP2500 || MED14184/JP2414 || MED14184A/JP2414A || MED21394P/JP2302P || MED2457S/JP8303 || MED2505/JP2510 || MED3110A/JP3003A || MED3110S/JP3003 || MED3130S/JP3008 || MED3140S/JP3005 || MED3820A/JP3102A || MED3820S/JP3102 || MED4202S/JP4003 || MED6052-53 || MED8610S/JP8005 || MED91263 || MED96570-021 || MEDDYNJ01201H || MEDDYNJ05933 || MEDDYNJO5933 || MEDDYNJP8201 || MEDSPT-2314/JP2314HD || MEG0012 || MEG0020 || MEG0035H || MEG0039H || MIC390-310 || MIC6131 || MIC6237 || MIC670-308 || MIC710-111 || MIC81010 || MPS5001689 || OLS20-1410KI || ORSORS-300 || Q2M20-1370 || RMITF-3646-0 || SMI4116 || SMI4615 || SMI4616 || SMI71111579 || SMI7204727 || SMI72200195 || SPIXDWIK28 || STR1608-2-59 || STR1608-2-63 || STR206-16 || STR206-546 || STR250-070-530 || STR250-070-540 || STR275-802-000 || STR306-553 || STR350-202-000 || STR3910-075-500 || STR3910-075-501 || STR3910-075-650 || STR3910-075-651 || STR3910-075-800 || STR400-800 || STR501-140-50 || STR5120-103-15 || STR606-563 || STR620-030-301 || STR620-030-407 || STR620-30-301 || SYN55.36E || SYNSDLB || TELDP-40K || TELMDP-40K || TER5842 || TERL7328 || TEX311033-000 || USE00712031 || VALE1450-6 || VALE1510 || VALE2350H || VALE2450H || VALE2505-10FR || VALE2515H || VALE2516H || WAL909009 || WEC528235 || WEL24-6001 || XOM1014242 || XOM10-46001 || XOM1850200 || XOM31-55631 || XOM31-55632 || XOM31-55636 || XOM31-55637 || XOM31-55638 and || XOM8225825

Gastroenterology-Urology Devices

2

No

AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, MA, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, WA, WI, and WV OUS: CANADA

TURP Electrodes || Model #'s: || CIRMLE-24-012 || CIRMLE-24-015 || OLYA22205C || STO27050F || STO27050G and || STO27050NK || Reprocessed endoscopic electrodes are intended to be used for vaporization, ablation, coagulation and/or resection for soft tissue in the prostate and bladder as well as when ablation and coagulation are required in gynecological and urological surgical procedures.