Procedure Kit

Disposable products

all recent lots of the following kit catalog numbers PB53VDOCF, PB54ADSNO, PBCGCSEZC, PBCGDKEZC, PBHFVDLRG, PBVBSCNMK, PC21OHHOF, PC43CCLGC, PC43OH79D, PECGCL16M, PECGET16D, PEOCMEBL1, PEOCMEBLD, PEVTCESWV, PG69VSUS1, PG69VSUSF, PGCGOTUI8, PH76OTMDS, PH76TCMDR, PL23CSAML, PL23VDMPY, PL29OTRMU, PL41CSHSO, PL41VD16I, PL41VD87F, PL42VGTMG, PL42VGTMH, PL42VGTMI, PL54OTSMG, PL57DVSCI, PL57SCSCG, PL73CSSJU, PL73FBDWC, PL81CS99M, PL81VDSFX, PL8FCSSVA,  PL8FVDSVB, PLCGLR52A, PLCGOTMJU, PLCGVD66B,  PLCNCSHSW, PLCNLRLVU, PLVBCSSFR, PLVQMBPAD,  PN46CRKMA, PN48NNCHB, PNCGSPCDR, PNOCCRBLF,  PNVMCFBHG, PNVMCRBHM, PP15ICFCK, PPOCLGBSN,  PU40TRSOJ, PUOCOTSO1, PW82BSTCQ, PZ15LRFCC,  PZ51BCA701, PZ51BCA70C, PZMHADFBH, PZMHNAKYG,  PZOCADBSD, PZOCADFRB, PZOCBCGVD, PZVBOTANMS,  PZVZOTMIE, SAM55AMQMC, SAN12MPWCD, SAN21MYHOD,  SAN23AGDHC, SAN23ANDHF, SAN26BTACB, SAN31PPELF,  SAN48CCCHP, SANHDMRUMA, SANHDPRPIA, SBA13BNMGC, SBA13BNMGD, SBA18LCSCJ, SBA24BBMMA, SBA33PMSMA, SBA33PMSMB, SBA44IRMDC, SBA4APEJHE, SBB32BBNMD, SBB32BBNME, SBB53BTEVD,  SBB55BBMMG, SCV19OHCH6, SCV22AOKMA, SCV43CVBRI,  SCV43OHMWQ, SCV44NUHWA, SCV51VCKKD, SCVHBHSTMC, SEN13ORBWK, SEN19BSFMF, SEN31NSLUQ, SEN31PPLUK, SEN31PPNMA, SEN31TALUP, SEN31THLUR, SEN51HDKKD, SEN5CEPGSC, SID51STKKA, SMA32EAHSA, SMA33EACBC, SNE11PMDO2, SNE11PMDOB, SNE12EPNEA, SNE19CRCHU, SNE32CPSV1, SNE32CPSVC, SNE32CPSVE, SNE32CPSVF, SNE35LFBHB, SNE35LMBHI, SNE36STWPH, SNE48LPWLC, SNE51LMKKG, SNU23BSCHF, SNU42BSNKC, SOP21BSDKC, SRI63ACUMC, SRIGS0049M, SRINU0546N, SRINU0546O, SRINU0866J, SRIOR0870H, SRIOR0870I, SRIOR0871K, SRIOR0871L, UMA24CE43T, UMA24VA439 and UMA24VA43S

General and Plastic Surgery Devices

2

No

Nationwide Distribution including California, Florida, Illinois, Kentucky, Minnesota, Missouri, Ohio, Tennessee, Washington, West Virginia and Wisconsin

Presource Custom Sterile Surgical and Procedure Kits; general surgery trays; Cardinal Health, McGaw Park, IL 60085; The kit catalog numbers listed in the code information section below contain one or more of the following listed components for which Cardinal Health has been unable to confirm the manufacturer's compliance with section 502(o) of the FD&C; Act: || a) 24" Infant Tape Measure, component 30942P; || b) Silicone Tubing, component SFM3-4450; || c) Triple Dye Drug, 10 unit dose, component PM1022; || d) Assembly Swabstick, component PS004; || e) 18x26 Poly Lined Towel, component 8580Z; || f) Disposable Vein Stripper, component 63-0431; || g) Cotton Glove, Large, White, PR, NS, component 1051; || h) Cotton Glove, Medium, White, PR, NS, component 1051M; || i) 6 Inch Metric-Inch Ruler, component 18C-Thru; || The kits are custom packed with all of the specific disposable class 1 and 2 devices required by the customer for specific types of surgery and medical procedures. These packs are then sterilized and are ready to be used by the customer for the specific procedure.

all recent lots of the following kit catalog numbers 03-2503F 03-2503H, 03B5615C, 4628, BA3CG4740K, BAB239109A, BAB920079C, MA1567670P, MA2CG6972D, MAN21ATAMC, MAT453740O and MATW11527D

General and Plastic Surgery Devices

1

No

Nationwide Distribution including California, Florida, Illinois, Kentucky, Minnesota, Missouri, Ohio, Tennessee, Washington, West Virginia and Wisconsin

Presource Custom Sterile Surgical and Procedure Kits; surgical trays; Cardinal Health, McGaw Park, IL 60085; The kit catalog numbers listed in the code information section below contain one or more of the following listed components for which Cardinal Health has been unable to confirm the manufacturer's compliance with section 502(o) of the FD&C; Act: || a) Adhesive Remover Wipes, component 050-0415; || b) Perineze Perineal Witch Hazel Pad, component 505040A || c) 24" Infant Tape Measure, component 30942P; || d) Triple Dye Drug, 10 unit dose, component PM1022; || The kits are custom packed with all of the specific disposable class 1 and 2 devices required by the customer for specific types of surgery and medical procedures. These packs are then sterilized and are ready to be used by the customer for the specific procedure.

Lot Numbers 07912-06 12912-04

General and Plastic Surgery Devices

1

No

Nationwide Distribution-USA (nationwide) including the states of AZ, CA, FL, GA, IL, KS, MA, MI, NC, NJ, OH, PA, TN, TX, VA, and WI.

FAST Procedure Kit. || Intended for use as a Minor Surgical Procedures Tray.

Corresponding Lot numbers: 1) 588948, 2) 588495 and 3)588480. Expiration date for these lot numbers: 12/2013.

General and Plastic Surgery Devices

2

No

USA Nationwide Distribution including the states of: IL, GA, CA, NY OH, AZ, TX, NE, FL, PA, NC, WI, AL, IN, CO, MO, MT, NE, MA, VA, AK, IN, MI, NJ, MD, TN, CT, WA, MN

AngioDynamics VenaCure EVLT NeverTouch-FRS PROCEDURE KIT under the following labeling: || 1) Gold-Tipped Fiber 45cm Kit, Catalog Number: 11403301; 2) Gold-Tipped Fiber 65cm Kit, Catalog Number: 11403302; 3) Gold-Tipped Fiber 90cm Kit, Catalog Number: 11403304. || Product Usage: || This device is intended to be used to measure the refractive power and the radius of corneal curvature of the human eye.