3 results
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22ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Microtek Medical, Inc., Microscope Drape for Zeiss Standard Model/Catalog Number: 70890655 Product Description: The Microtek Medical, Inc., Microscope Drape for Zeiss Standard is intended is to protect surgical microscopes from contamination during various procedures. Labeling for the product is as follows: (1.) INNER CARTON LABEL: Distributed by; MICROTEX, MICROSCOPE DRAPE FOR ZEISS STANDARD, 20 x 66 (51cm x 168 cm), REF 70890655, QTY 12, LOT DA102032, Microtek Medical, Inc., Columbus, MS 39702, www.microtekmed.com, CE0044, EC, REP, Microtek Medical B.V. Zutphen, The Netherlands, Manufactured in the Dominican Republic of U.S. Materials, STERILE, EO, 2015-07, (01)30748426064206, (17) 150700(10) DA102032, INNER, Rev. C. (2.) PRODUCT LABEL: Distributed by; MICROTEX, MICROSCOPE DRAPE FOR ZEISS STANDARD, 20 x 66 (51cm x 168 cm), REF 70890655, QTY 1, LOT DA102032, Microtek Medical, Inc., Columbus, MS 39702, www.microtekmed.com, CE0044, EC, REP, Microtek Medical B.V. Zutphen, The Netherlands, Manufactured in the Dominican Republic of U.S. Materials, STERILE, EO, 2015-07, (01) 00748426064205, (17) 150700(10) DA102032, EACH, Rev. D. (3.) CARTON LABEL: Distributed by; MICROTEX, MICROSCOPE DRAPE FOR ZEISS STANDARD, 20 x 66 (51cm x 168 cm), REF 70890655, QTY 12/CS, LOT DA102032, Microtek Medical, Inc., Columbus, MS 39702, www.microtekmed.com, CE0044, EC, REP, Microtek Medical B.V. Zutphen, The Netherlands, Manufactured in the Dominican Republic of U.S. Materials, STERILE, EO, 2015-07, (01)50748426084200, (17) 150700(10) DA102032, INNER, Rev. D.
FDA Recall
Terminated
·Microtek Medical, Inc.·Product code KKX·August 23, 2010
***REF #250***TAPSCOPE 550F. Each pouch contains one (1) 18 French esophageal stethoscope with bipolar pacing and recording electrodes with a YSI 400 series female connector thermistor. LOT xxxxxxx 400095-0250-C 100902. www.cardiocommand.com. ***REF #250-0010***TAPSCOPE 550F CONTAINS: Ten (10) 18 French esophageal stethoscopes with bipolar pacing and recording electrodes with YSI 400 series female connector thermistors. NON-STERILE. SINGLE USE ONLY. DO NOT REUSE. CAUTION: Federal (U.S.A.) law restricts this device to sale, distribution and use by or on the order of a licensed physician. Manufacturer: CARDIOCOMMAND, INC. Tampa, FL USA. (800) 231-6370 (813) 289-5555. www.cardiocommand.com. LOT xxxxxxx 400156-B 091101. ***REF #250-0025***TAPSCOPE 550F Contains: Twenty five (25) 18 French esophageal stethoscopes with bipolar pacing and recording electrodes with YSI 400 series female connector thermistor. FOR SINGLE USE ONLY. DO NOT REUSE. NON-STERILE. CAUTION: Federal (U.S.A.) law restricts this device to sale, distribution and use by or on the order of a licensed physician. Read Model 2A operator's manual prior to initiating pacing procedures. Manufacturer: CARDIOCOMMAND, INC.Tampa, FL USA 33607. (800) 231-6370(813) 289-5555. www.cardiocommand.com. 400216-A 100902.
FDA Recall
Terminated
·Cardiocommand Inc.·Product code LPA·October 25, 2010
***REF #200***TAPSCOPE 550. Each pouch contains one (1) 18 French esophageal stethoscope with bipolar pacing and recording electrodes with a YSI 400 series male connector thermistor. LOT xxxxxxx 400095-0200-C 100902. www.cardiocommand.com. ***REF #200-0010***TAPSCOPE 550 CONTAINS: Ten (10) 18 French esophageal stethoscopes with bipolar pacing and recording electrodes with YSI 400 series male connector thermistors. NON-STERILE. SINGLE USE ONLY. DO NOT REUSE. CAUTION: Federal (U.S.A.) law restricts this device to sale, distribution and use by or on the order of a licensed physician. Manufacturer: CARDIOCOMMAND, INC. Tampa, FL USA. (800) 231-6370 (813) 289-5555. www.cardiocommand.com. LOT xxxxxxx 400155-B 091101. ***REF #200-0025***TAPSCOPE 550 Contains: Twenty five (25) 18 French esophageal stethoscopes with bipolar pacing and recording electrodes with YSI 400 series male connector thermistors. ***LOT xxxxxxx***FOR SINGLE USE ONLY. DO NOT REUSE. NON-STERILE. CAUTION: Federal (U.S.A.) law restricts this device to sale, distribution and use by or on the order of a licensed physician. Read Model 2A operator's manual prior to initiating pacing procedures. Manufacturer: Tampa, FL USA 33607. (800) 231-6370 (813) 289-5555. www.cardiocommand.com. 400215-A 100902.
FDA Recall
Terminated
·Cardiocommand Inc.·Product code LPA·October 25, 2010