Recall Z-0559-2009
Sterilmed Inc · initiated August 8, 2008
Product
Harmonic Scalpel Model #'s: ETHACE14S ETHACE23P ETHACE36P ETHCS14C ETHFCS9 ETHHDH05 ETHLCS-C5 and ETHLCSC5HA Intended for use in soft tissue incisions when bleeding control and minimal thermal injury are desired.
Codes / lots: n/a
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 taken
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.
Details
- Recall number
- Z-0559-2009
- Initiated
- August 8, 2008
- Posted by FDA
- January 13, 2009
- Terminated
- April 26, 2011
- Product code
- NLQ – Single-Use Reprocessed Ultrasonic Surgical Instruments
- Quantity
- 14
- 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
- Recalling firm
- Sterilmed Inc, Osseo, MN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0546-2009 | Balloon Inflation Device Model #'s: MED15-105 MED15-106 and SCI04527-01 The reprocessed…SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed… | 08/08/2008Terminated |
| Z-0547-2009 | Bed Check Model #'s: BED65815-021 BED65815-025 BED65815-025IT BED65815-030 BED65815-031…SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed… | 08/08/2008Terminated |
| Z-0548-2009 | Drill Bits Model #'s: DEP14043 MIC8053-019 RIC21-0438 RIC21-0439 RIC21-0441 RIC21-0442…SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed… | 08/08/2008Terminated |
| Z-0549-2009 | Biopsy Forceps, Hot Model #'s: BAL60110 BAR000852 BAR000854 and MIC1550 Laparoscopic…SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed… | 08/08/2008Terminated |
| Z-0550-2009 | Burrs Model #'s: ANSL-3SB ANSL-5D ANSQD11-4OVDC HAL5056-118 HAL5056-166 HAL5091-106…SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed… | 08/08/2008Terminated |
| Z-0551-2009 | Cardiac Imaging Catheter Model #'s: ACU08267996 and ACU55790 Intended for intravascular…SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed… | 08/08/2008Terminated |
| Z-0552-2009 | Colorado Electrodes Model #'s: COLN104A COLN112A and STRN103A Intended for precision…SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed… | 08/08/2008Terminated |
| Z-0553-2009 | Compression Sleeves Model #'s: HUNDVT10-1 and KEN5329 The SterilMed Intermittent…SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed… | 08/08/2008Terminated |
| Z-0554-2009 | EP Cables Model #'s: BAR560004P BIOC10MR10MSTKS BIOC5-MH/NAVMH-S CORC6-MR10/EPTR-S…SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed… | 08/08/2008Terminated |
| Z-0555-2009 | EP Catheter Model #'s: BIOD6-DR-005-RT BIOD6-DR-010-RT DAI401381 DAI401449 DAI401904…SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed… | 08/08/2008Terminated |
| Z-0556-2009 | External Fixation Device Model #'s: ORT99-36501 SYN390.005 SYN390.008 SYN394.84…SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed… | 08/08/2008Terminated |
| Z-0557-2009 | Femoral Compression Device Model #'s: RAD11163 Intended for use in the compression of…SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed… | 08/08/2008Terminated |
| Z-0558-2009 | Guidewires - Endoscopic (Jag Wires) Model #'s: MIC5658 and MIC630-100 Intended to be…SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed… | 08/08/2008Terminated |
| Z-0560-2009 | Lap Instruments/Graspers/Forceps - HOT Model #'s: AUT173016 AUT174301 AUT176643…SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed… | 08/08/2008Terminated |
| Z-0561-2009 | Lap Instruments/Graspers/Forceps - COLD Model #'s: AUT173030 AUT174233 AUT174317…SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed… | 08/08/2008Terminated |
| Z-0562-2009 | Laser Probe Model #': SYN55.26.25 Reprocessed laser probes are part of a laser delivery…SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed… | 08/08/2008Terminated |
| Z-0563-2009 | Masks - Laryngeal Model #'s: AMB321-300-000 AMB321-400-000 AMB321-500-000 LMA12015…SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed… | 08/08/2008Terminated |
| Z-0564-2009 | Multi-Clip Applier Model #'s: APPCA080 AUT134031 AUT134046 AUT134051 AUT134053 AUT176625…SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed… | 08/08/2008Terminated |
| Z-0565-2009 | Phaco Tips Model #'s: ALC30RTS ALC8065740806 ALC8065740809 ALC8065740837 ALC8065740839…SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed… | 08/08/2008Terminated |
| Z-0566-2009 | Rasps Model #'s: KOMKM5100-37-113 KOMKM-82 STR1675-115 STR5100-37-113 and STR5100-37-115…SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed… | 08/08/2008Terminated |
| Z-0567-2009 | Retractors Model #'s: ADE3204 BOS820-175 LON3304 and LON3334-4G A manual surgical…SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed… | 08/08/2008Terminated |
| Z-0568-2009 | RF Arthroscopy Probe Model #'s: ARTA1325-01 ARTA1335-01 ARTA1345-01 ARTA1730-01…SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed… | 08/08/2008Terminated |
| Z-0569-2009 | Saw Blade Model #'s: BIO506112 BIO506113 DEP2555-91-000 DEP5627-11-500 HAL5023-118…SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed… | 08/08/2008Terminated |
| Z-0570-2009 | Scissor Tips Model #'s: AESPO888 AESPO889 ENCES0102 MIC3112 MIC3122 MIC3142 MIC3152…SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed… | 08/08/2008Terminated |
| Z-0571-2009 | Stone Retrieval Basket Model #': BOS390-105 Used to entrap and remove renal stones and…SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed… | 08/08/2008Terminated |
| Z-0572-2009 | Tourniquet Cuffs Model #'s: INSDT-7024-02 INSDT-7218-01 SMI553322 SMI7010-7002…SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed… | 08/08/2008Terminated |
| Z-0573-2009 | TURP Electrodes Model #'s: CIRMLE-24-012 CIRMLE-24-015 OLYA22205C STO27050F STO27050G…SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed… | 08/08/2008Terminated |
| Z-0574-2009 | Open & Unused Items - This refers to a sterilization service provided by by SterilMed…SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed… | 08/08/2008Terminated |
| Z-0575-2009 | Biopsy Forceps, Cold Model #'s: BAR000386 BAR000388 MIC1012 MIC1331 MIC1333 MIC1337…SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed… | 08/08/2008Terminated |
| Z-0576-2009 | Taps Model #'s: SYN311.15 SYN311.190 SYN311.39 and SYN311.32 An orthopedic manual…SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed… | 08/08/2008Terminated |