RECALLS AND FIELD CORRECTIONS 8

RECALLS AND FIELD CORRECTIONS 8 - ENFORCEMENT REPORT FOR...

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ENFORCEMENT REPORT FOR SEPTEMBER 29, 2010 RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II ___________________________________ PRODUCT 1) Infinity Delta/Gamma X XL Patient Monitor. Portable monitor used to monitor vital signs of neonatal, pediatric, and adult patients for bedside and transport applications. Catalog Number: MS18597. Recall # Z-2283-2010 2) Infinity Delta/Gamma X XL Patient Monitor. Portable monitor used to monitor vital signs of neonatal, pediatric, and adult patients for bedside and transport applications. Catalog Number: MS18852. Recall # Z-2284-2010 CODE None RECALLING FIRM/MANUFACTURER Draeger Medical Systems, Inc., Telford, PA, by letters on June 4, 2010. Firm initiated recall is ongoing. REASON Monitor keys may become inoperative or activate spontaneously. This may cause a membrane switch panel malfunction, which could result in the monitor discharging a patient automatically. VOLUME OF PRODUCT IN COMMERCE 9,475 units DISTRIBUTION Nationwide and Internationally ___________________________________ PRODUCT 1) Deknatel Bondek Plus Polyglycolic Absorbable Surgical Sutures, Bon+BG BR 3-0 DSL 19 1N (45cm), Teleflex Medical. Bondek and Bondek Plus Synthetic Absorbable Surgical Sutures intended uses are in general surgical procedures where general soft tissue approximation and/or ligation are performed, including use in ophthalmic procedures, but not for use in cardiovascular and neurological procedures. Catalog Number: EP4084N. Recall # Z-2286-2010; 2) Deknatel Bondek Plus Polyglycolic Absorbable Surgical Sutures, Bon+VI R 0 HRX27 1N (70 cm), Teleflex Medical. Catalog Number: EP1081P. Recall # Z-2287-2010 CODE 1) Lot number: 02A0801449; 2) Lot number: 02A0801448, 02A0802800, 020A802802 and 02A0801433 RECALLING FIRM/MANUFACTURER Recalling Firm: Telefelx Medical, Durham, NC, by letter dated February 1, 2010. Manufacturer: Teleflex Medical, Nueva Laredo, Mexico. Firm initiated recall is ongoing. REASON Labeling error; The Bondek Suture product inside the box are of a different catalog number than labeled on the outer box. VOLUME OF PRODUCT IN COMMERCE 17 sales units (24 packs per sales unit/408 units) DISTRIBUTION
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Nationwide and Germany ___________________________________ PRODUCT ReliaMed Deluxe Portable Adjusting Table. Product is a medical table used on patients for massage and chiropractic treatment. Recall # Z-2288-2010 CODE The tables do not bear lot or serial numbers; however there are two device identification numbers representative of two different colors. ZZRNT100BL (blue) ZZRMT100BLK (black) RECALLING FIRM/MANUFACTURER Recalling Firm: MDC Acquisition Co., Rancho Cucamonga, CA, by letters in April 2010. Manufacturer: Huangshan City Shexian Comfort Massanage Applia, Huangshan, China. Firm initiated recall is ongoing. REASON
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This note was uploaded on 07/10/2011 for the course ECON 101 taught by Professor Tuner during the Spring '11 term at Solano Community College.

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RECALLS AND FIELD CORRECTIONS 8 - ENFORCEMENT REPORT FOR...

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