Z-0574-2009

Open & Unused Items - This refers to a sterilization service provided by by SterilMed, Inc. (devices were not...

Name: Z-0574-2009 Open & Unused Items - This refers to a sterilization service provided by by SterilMed, Inc. (devices were not...
Creator: Sterilmed Inc
Published: 2008-08-08
License: https://open.fda.gov/license/

Sterilmed Inc / initiated 2008-08-08 / Terminated / root cause: packaging

FDA source

Sterilmed Inc began a recall of 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... on 2008-08-08. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0574-2009
Status: Terminated
Initiated: 2008-08-08
Posted: 2009-01-13
Terminated: 2011-04-26
Recalling firm: Sterilmed Inc
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
Product code: FWZ Operating Room Accessories Table Tray
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
Root cause tag: packaging
FDA root 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
Product codes and lots: n/a

Product code FWZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)