Welch Allyn Inc

Code dates between June 20, 2003 and October 8, 2003. (Codes found on outer carton only.)

Cardiovascular Devices

2

No

The product was sold thru 11 distributors. The product was shipped to end users nationwide. There is one foreign distributor in Singapore. In addition, Welch Allyn shipped product to their affiliates in Ireland, Australia, and South Africa.

NEONATE 4 DISPOSABLE BLOOD PRESSURE CUFF WITH 2 TUBES, a disposable one piece cuff, for single patient use only. Sold under the Welch Allyn ''Tycos'' and Allegiance ''Tactics'' labels. The ''4'' represents the cuff size. (4 = 6.9 to 11.7 cm). These are sold in various configurations and assigned different part numbers. Devices are labeled as follows: || Welch Allyn Tycos #5082-104-2 (10 pack/2 tubes); || Welch Allyn Tycos #5082-104-2CL (10 pack/2 tubes, with clamp); || Welch Allyn Tycos #5082-241-10 (5 pack/2 tubes, multi-size pack); || Allegiance Tactics #30502-113 (case of 40/2 tubes); || Allegiance Tactics #30502-213 (case of 40/2 tubes, with clamp); || Welch Allyn Tycos/Allegiance #5082-241-16 || Firm on the label: (1) Welch Allyn Tycos and Tycos/Allegiance label (package insert and shipping case only): ''Welch Allyn, Inc., Skaneateles Falls, NY''; (2) Allegiance Tactics label ''Distributed by: Allegiance Healthcare Corp., McGaw Park, IL 60085-6787 USA''.

Code dates between June 20, 2003 and October 8, 2003. (Codes found on the outer carton only.)

Cardiovascular Devices

2

No

The product was sold thru 11 distributors. The product was shipped to end users nationwide. There is one foreign distributor in Singapore. In addition, Welch Allyn shipped product to their affiliates in Ireland, Australia, and South Africa.

NEONATE 4 DISPOSABLE BLOOD PRESSURE CUFF WITH 1 TUBE, a disposable one piece cuff, for single patient use only. Sold under the Welch Allyn ''Tycos'' and Allegiance ''Tactics'' labels. The ''4'' represents the cuff size. (4 = 6.9 to 11.7 cm). These are sold in various configurations and assigned different part numbers. Devices are labeled as follows: || Welch Allyn Tycos #5082-104-1 (10 pack/1 tube); || Welch Allyn Tycos #5082-241-9 (5 pack/1 tube, multi-size pack); || Allegiance Tactics #30502-113S (case of 40/1tube); || Welch Allyn Tycos/Allegiance #5082-241-15 (5 pack/1 tube, multi-size pack); || Firm on label: (1) Welch Allyn Tycos and Tycos/Allegiance label (package insert and shipping case only): ''Welch Allyn, Inc., Skaneateles Falls, NY''; || (2) Allegiance Tactics label ''Distributed by: Allegiance Healthcare Corporation, McGaw Park, IL 60085-6787 USA''

all lots

Obstetrical and Gynecological Devices

2

No

Nationwide, Puerto Rico and foreign distribution to the following countries: Australia, Bahamas, Bahrain, Belgium, Bermuda, Cambodia, Canada, Czech Republic, China, Cyprus, Denmark, Egypt, France, Germany, Great Britain, Greece, Guam, Guatemala, Iceland, India, Israel, Japan, Kenya, Kuwait, Malaysia, Mexico, Netherlands, New Zealand, Norway, Oman, Panama, Peru, Philippines, Poland, Russia, Saudi Arabia, Serbia, Singapore, South Africa, Spain, Sri Lanka, Thailand, Turkey, United Arab Emirates.

Welch Allyn KleenSpec Corded Illumination System, Vaginal Speculum Lighting System, Model Number 78x Series Illuminator, REF 901070, Catalog Numbers 78800, 73410, 73412, 73414, 73416, 78810, 78812, 78814 and 78816, Rx ONLY

Code dates between May 13, 2003 and January 23, 2004. (Codes found on outer carton only)

Cardiovascular Devices

2

No

Direct accounts include distributors, medical facilities, an exporter and 7 foreign consignees.

NEONATE 5 DISPOSABLE BLOOD PRESSURE CUFF WITH 2 TUBES, a disposable 1 piece cuff for single patient use only. Sold under the Welch Allyn ''Tycos'' label with Part # 5082-105-2, 5082-105-2CL, and sold as part of a multi-pack (1 of each size) with Part #5082-241-10 - Welch Allyn Inc., Skaneateles Falls, NY; Allegiance Healthcare ''Tactics'' label with Part # 30502-114 and 30502-214 - Allegiance Healthcare Corp., McGaw Park, IL; and Arden label with Part # 5084-105-2 and 637-5084-105-2 - Arden, Skaneateles, NY.

Code dates between May 13, 2003 and January 23, 2004. (Codes found on outer carton only)

Cardiovascular Devices

2

No

Direct accounts include distributors, medical facilities, an exporter and 7 foreign consignees.

NEONATE 5 DISPOSABLE BLOOD PRESSURE CUFF WITH 1 TUBE, a disposable 1 piece cuff for single patient use only. Sold under the Welch Allyn ''Tycos'' label with Part # 5082-105-1 and sold as part of a multi-pack (1 of each size) with Part #5082-241-9 - Welch Allyn Inc., Skaneateles Falls, NY; Allegiance Healthcare ''Tactics'' label with Part # 30502-114S - Allegiance Healthcare Corp., McGaw Park, IL; and Arden label with Part # 5084-105-1- Arden, Skaneateles, NY.