Class 2 Device Recall

• Date Initiated by Firm: August 08, 2008
• Date Posted: January 13, 2009
• Recall Status: Terminated on April 26, 2011
• Recall Number: Z-0574-2009
• Recall Event ID: 49510
• Product Classification: Operating Room Accessories Table Tray - Product Code FWZ
• Product: 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
• Code Information: n/a
• Recalling Firm/ Manufacturer: Sterilmed Inc; 11400 73rd Ave N Ste 100; Osseo MN 55369-5562
• For Additional Information Contact: 763-488-3400
• Manufacturer Reason for Recall: SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed within a pouch. The removal is being conducted because the possibility exists that some of the pouches were not properly sealed on one end. A breach in packaging seal or a failure in packaging integrity has the possibility of risk to the patient in terms of transmitting organisms capable
• FDA Determined Cause: Packaging process control
• Action: Consignees were notified of the recall via verbal communication in person by on-site technician and or their local sales representative on 8/8/08. Others were contacted via fax or e-mail followed by on-site visits 8/11/08. SteriMed also provided consignees (Materials Manager/Risk Manager) with a "Urgent Product Removal" recall letter (August 14, 2008) in person informing them of the potential of receiving affected product. Included in the Product Removal Notification was a Customer Reply Form to inventory quantity of product received and quantity returned. Contact SterilMed, Inc. at 1-888-541-0078 for assistance.
• Quantity in Commerce: 469
• Distribution: 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
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.