SF05200MV, SF05200SV, SF06200MV, SF06200SV | See FSN

MD: Multiple peripheral artery stent, bare-metal

md

Medical Device Safety Alert: Cordis S.M.A.R.T. ® CONTROL® Nitinol Stent System

Model Catalog: SBA30SRXXA (Lot serial: 417174.); Model Catalog: SBA30SRXXA (Lot serial: 299718 306001 314825); Model Catalog: SBA30SRXXA (Lot serial: 393094 400809 404813); Model Catalog: SOP30BRXXX (Lot serial: 374415)

SKIN RETRIEVAL PACK

Model Catalog: K6328 (Lot serial: 119574.); Model Catalog: K6328 (Lot serial: 118761 118762 118763)

SCD TUBING ASSEMBLY

md

Model Number: D135601 Lots #'s 15958389LA, 15959088LA, 15959090LA, 15968753LA, 15968806LA, 15968810LA, and 15968813LA, with Exp Date 8/31/2014 Lots #'s 15976735L, 15976820L, 15976823L, 15978174L, 15978179L, 159784180L, and 15978181L with Exp Date 9/30/2014

Gastroenterology-Urology Devices

2

No

Distributed in Germany only.

RenLane Renal Denervation Catheter; Cat No.: D135601. || Used in adults patients (>18 years) with drug resistant hypertension to denervate the renal arteries to reduce blood pressure.

medical_device

Surgical equipment/ Anaesthesia

medical_device

see letter | see letter

MD: Catheter

see letter | see letter

MD: Catheter

Cardinal Health: Protexis Neoprene Surgical Glove

Lot numbers R0305581, R0305159, R0305284, R0305286, R0305155 and R0305104.

Cardiovascular Devices

2

No

Distributed to 35 consignees throughout the US and other consignees in 11 countries worldwide.

Product is a Powerflex P3 Dialation Catheter. Product is labeled in part: ''***POWERFLEX P3***Cordis***a Johnson and Johnson company***ENDOVASCULAR***STERILE EO***Cordis Europa N.V., 9301 LJ Roden, The Netherlands***''

see list

MD: Surgical procedure kit, general-purpose, non-medicated, single-use

Model Catalog: PRISMA TPE2000 SET (Lot serial: ALL LOTS); Model Catalog: PRISMA ST60 PRE SET (Lot serial: ALL LOTS); Model Catalog: PRISMA ST100 PRE SET (Lot serial: ALL LOTS); Model Catalog: PRISMA M100 PRE SET (Lot serial: ALL LOTS); Model Catalog: PRISMAFLEX HF20 SET (Lot serial: ALL LOTS); Model Catalog: PRISMAFLEX ST100 SET (Lot serial: ALL LOTS); Model Catalog: PRISMAFLEX ST60 SET (Lot serial: ALL LOTS); Model Catalog: PRISMAFLEX ST150 SET (Lot serial: ALL LOTS); Model Catalog: PRISMAFLEX M60 SET (Lot serial: ALL LOTS); Model Catalog: PRISMAFLEX M150 SET (Lot serial: ALL LOTS); Model Catalog: OXIRIS (Lot serial: ALL LOTS); Model Catalog: PRISMAFLEX HF1400 (Lot serial: ALL LOTS); Model Catalog: PRISMAFLEX HF1000 (Lot serial: ALL LOTS); Model Catalog: PRISMAFLEX M100 SET (Lot serial: ALL LOTS); Model Catalog: PRISMAFLEX TPE 2000 (Lot serial: ALL LOTS); Model Catalog: PRISMAFLEX TPE 1000 (Lot serial: ALL LOTS)

PRISMA SET

Model Catalog: V1485 (Lot serial: 0060060614 0060072370); Model Catalog: V1485 (Lot serial: 0060076562 0060090805); Model Catalog: V1485 (Lot serial: 0060111419.)

PRIMARY ADDITIV ADM SET W.CHECK VALVE

Model Catalog: V1485 (Lot serial: 60100328)

PRIMARY ADDITIV SET W/CHECK VALVE

Model Catalog: 7450 (Lot serial: N/A)

Prevalon AirTAP Booster Pump

Model Catalog: LM8035 (Lot serial: SN 44711); Model Catalog: LM8035 (Lot serial: SN 46675)

PRESSUREGUARD EASY AIR MATTRESS