Symbiosis Corp.

Pouch codes are:Catalog No. 12160-01J, UPN H7491216001J1, batch 4536936, expiration date of 2004-01. The five pack box codes are: Catalog No. 12160-01J, UPN H7491216001J2, batch 4562262, expiration date 2004-01.

Cardiovascular Devices

2

No

Product was distributed to 7 hospital accounts in FL, KS, NH, IA, PA, MI AND CA.

Scimed ChoICE PT ''J'' Tip 182 cm Guide Wire, a single use, sterile (EO), device packaged in a carrier tube, which is held in a coil by plastic clips. The carrier tube assembly of the guide wire is sealed into a pouch. The pouch assembies are packaged in a five-pack product box.

Individual Devices in Pouches with Catalog No. 12155-01, UPN H74912155011, Lot Number 4773987, exp. date 2004-5. These pouches were packaged in two lots of five-pack boxes with the following codes: Catalog 12155-01, lot 4791304 Catalog 12155-01, lot 4798294

Cardiovascular Devices

2

No

Recalled product was shipped to 107 domestic hosptials nationwide and to 2 international acccounts.

Scimed ChoICE PT Extra Support PTCA Guide Wire with ICE Hydrophilic Coating, 300 cm length

Individual devices in pouches as follows: Catalog No. 14914-01 UPN H74914914011 Lot Number Expiration Date  4772607 2004-0 4772610 '' 4762379 '' 4762384 '' 4772618 '' 4766619 '' 4758393 '' 4758432 '' 4753775 '' 4758389 '' 4758427 '' 4756521 '' 4762390 '' 4756485 '' 4753781 '' 4758397 '' 4758423 '' 4753783 '' 4753785 '' 4740328 2004-4 4753779 2004-5 4753759 '' 4753769 '' 4756534 '' 4756536 '' 4756531 '' 4724690 2004-4 4740329 '' 4736552 ''  The above PT Graphix¿ guide wire pouch lots were packaged in 18 lots of five-pack boxes with the following codes:  Catalog No. 1215T UPN H74914914012 Lot Number Expiration Date  4789558 2004-05 4791600 '' 4789558 '' 4791126 '' 4785009 '' 4787988 '' 4786427 '' 4783177 '' 4780051 '' 4780186 '' 4783316 '' 4780190 '' 4782079 '' 4780939 '' 4771889 '' 4777410 '' 4775761 '' 4776272 '' 4766792 ''

Cardiovascular Devices

2

No

Recalled product was shipped to 107 domestic hosptials nationwide and to 2 international acccounts.

Scimed PT Graphix Intermediate PCTA Guide Wire with ICE Hydrophilic Coating, 300 cm length.

Individual pouch codes are coded catalog # 12132-01, batch 4785750 expiration date 2004-05 and the five pack outer boxes are coded: Catalog No. 12132-01, batch 4806821 expiration date 2004-5.

Cardiovascular Devices

2

No

Product was distributed to hospitals in FL, MI, GA, OR, ID AND CT. 05.

Product is a ChoICE 182 cm Guide Wire, intended to facilitate placement of balloon dilatation catheters and other therapeutic devices during Percutaneous Transluminal Coronary Angioplasty (PTCA) procedures. The ChoICE guide wire contains a one-piece stainless steel core, which extends throughout the length of the wire and provides steerability and torqueability. The wire is tapered and formed at the distal tip. A radiopaque platinum spring coil surrounds the distal tip of the core wire. || The ChoICE Guide Wire is a single use, sterile (EO), device packaged in a carrier tube, which is held in a coil by plastic clips. The carrier tube assembly of the guide wire is sealed into a pouch. One side of the pouch is clear polyethylene/polyester laminate and the reverse side is Tyvek. The pouch assemblies are packaged in a five-pack product box. A flushing tool is included in the package to facilitate hydration of the coating with heparanized saline before use. || 1, page 1, is a copy of the pouch label. Exhibit 1, page 2 is a copy of the five-pack product box label. Exhibit 2 is a copy of the Directions for Use.

Pouch codes for the 180 cm length wuidewires are:  Catalog No. 46-591, UPN M001465910 Lot Number Use Before Date 4959940 2005-08 4959941 '' 4969651 '' 4969654 '' 4969655 '' 4969656 ''  The pouch codes for the 260 cm length guidewires are: Catalog No. 46-5912, UPN M001465920 Lot Number Use Before Date 4959945 2005-08 4959946 '' 4959944 '' 4959943 ''

Cardiovascular Devices

2

No

Product was distributed to 118 hospitals nationwide.

Medi-Tech Magic Torque Glidex hydrophilic coated guidewire, .035 inch/180 cm and .035 inch/260 cm lengths. Packaged in a sterile pouch and a three pack shelf box.