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Cook Medical Issues Global Recall of Select Lots of Central Venous Catheters and Pressure Monitoring Sets and Trays

For Immediate Release

February 10, 2016

Contact

Consumers

Cook Medical Customer Relations
FieldActionsNA@cookmedical.com
1-800-457-4500

Media

Moriah Sowders
moriah.sowders@cookmedical.com
812-339-2235, ext. 4357

 

Announcement

On January 6, 2016, Cook Medical initiated a voluntary recall of 360 specific lots of Single Lumen Central Venous Catheters and Pressure Monitoring Sets and Trays due to catheter tip fracture and/or separation. Globally, 17,827 devices are subject to this recall. The recalled products are specific versions and lot numbers of the Single Lumen Central Venous Catheter Sets and Trays, Single Lumen Pressure Monitoring Sets, Femoral Artery Pressure Monitoring Catheter Sets and Trays, and Radial Artery Pressure Monitoring Catheter Sets and Trays. These products are intended for use in venous or arterial pressure monitoring, blood sampling, and administration of drugs and fluids.

During an internal inspection, a catheter exhibited the potential for catheter tip fracture and/or separation. Further investigation revealed that the technique used by the product assembler while tipping the catheter likely contributed to this nonconformance. No reports of illness or injury have been associated with this issue to date. Potential adverse events that may occur as a result of catheter tip fracture and/or separation include loss of device function, the need for medical intervention to retrieve a separated segment, and complications resulting from a separated tip occluding blood flow to end organs. Examples of such complications include stroke, kidney injury, or damage to the intestines or limbs.

The Single Lumen Central Venous Catheters and Pressure Monitoring Sets and Trays in this recall were distributed globally between April 24, 2015, and October 23, 2015. Product can be identified by the part number and lot number that are provided on the outer package product label. The lot numbers for products that are subject to this recall can be found below:

Name of Device Reference Part Number Global Product Number Lot Number
Femoral Artery Pressure Monitoring Catheter Tray
C-NPMSY-501J-15 G13531 NS6054841, NS6054842, NS6075552, NS6082372, NS6082373
C-PMSY-300-FA G02962 NS5833887, NS5866959, NS5881272, NS5881334,NS5881335, NS5919925, NS6047449, NS6054847, NS6054848, NS6072526, NS6072555, NS6082379, NS6090277, NS6105921, NS6124989, NS6130501,NS6148639
C-PMSY-300J-FA G02795 NS5866961, NS5866962, NS5892115, NS5922709, NS5932844, NS5974256, NS6031988, NS6031990, NS6042578, NS6050052, NS6050053
C-PMSY-400J-FA G01925 NS6031992, NS6031993, NS6130504, NS6137424
C-PMSY-401-FA G02253 NS6054849
Femoral Artery Pressure Monitoring Catheter Set
C-NPMS-501J-15 G13332 6054830, 6054831, 6072436, 6078670, 6081720, 6083977
C-PMS-300-FA G02250 NS5833881, NS5881267, NS5881268, NS5892106, NS5892107, NS5892108, NS5914766, NS5922706, NS5928596, NS5932820, NS5932821, NS5967447, NS5967448, NS5967449, NS6014474, NS6014475, NS6014484, NS6014485, NS6042778, NS6042795, NS6042796, NS6050046, NS6063330, NS6063354, NS6075555, NS6100599, NS6100600, NS6108225, NS6124985
C-PMS-300J-FA G04021 NS5888542, NS5928597, NS6028553, NS6042797, NS6090273, NS6090274, NS6100601, NS6130149
C-PMS-301-FA G02598 5800570, 5860387, 5891906, 5980254, 6003160, 6062725,6143835, NS5830771, NS5866956, NS5866957, NS5881269, NS6014460, NS6042798, NS6050047, NS6075534, NS6075556
C-PMS-301J-FA G02755 5895598, 6129058, 6148613, NS5932822, NS5932837, NS5994907, NS6130498
C-PMS-400-FA G01909 6067782, 6139280, NS6042805, NS6130500
C-PMS-401-FA G02058 6049951, 6137353, 6139281
C-PMS-401J-FA G02089 6034986, 6049957, 6067784
Radial Artery Pressure Monitoring Catheter Tray
C-PMSY-250-RA G04528 6124812
C-PMSY-300-RA G01923 5793192, 5824526, 5884647, 5892068, 5942090, 5967410,6003167, 6059765, 6134128, 6153124, 6168137, 6254068
C-PMSY-301-RA G02052 5793193, 5866995, 5892069, 5942092, 6003168, 6025099, 6067664, 6168138
Radial Artery Pressure Monitoring Catheter Set
C-PMS-250-RA G02926 6049998, 6160195, 6160212, NS5898558, NS6063328, NS6178204, NS6178206
C-PMS-251-RA G02930 5895605, 6191185
C-PMS-300-RA G01908 5793196, 5800313, 5800443, 5800569, 5806981, 5810905, 5810917, 5824484, 5824546, 5824547, 5824548, 5866984, 5866985, 5866986, 5870319, 5881447, 5881519, 5889496, 5891905, 5911486, 5922847, 5922848, 5925742, 5928632, 5939446, 5939447, 5939448, 5976502, 6025016, 6025094, 6033768, 6034981, 6034983, 6050000, 6062738, 6062742, 6067675, 6067676, 6075206, 6075207, 6083936, 6083954, 6083985, 6083986, 6129056, 6148790, 6160236, 6165591, 6174974, 6175289, 6191362, 6269150, NS6063331, NS6108226, NS6170739, NS6170767
C-PMS-300-RA-CHOP G50148 5905252, 6003109
C-PMS-301-RA G02054 5793197, 5800571, 5800572, 5824485, 5824551, 5845063, 5864072, 5866988, 5873125, 5881151, 5881152, 5884641, 5884642, 5889464, 5892063, 5892064, 5922850, 5939431, 5942091, 5951549, 5953768, 5954322, 5967404, 5974281, 5994817, 5996926, 6003161, 6003162, 6017048, 6025095, 6025145, 6034984, 6042699, 6050002, 6075210, 6075211, 6075212, 6081723, 6083988, 6100756, 6124809, 6125111, 6148791, 6153122, 6160239, 6160240, 6168131, 6171368, 6187477, 6250532
C-PMS-400-RA G02092 6059759, NS6047396, NS6047397, NS6047398, NS6047399, NS6047440, NS6047442
C-PMS-301J-RA G02133 NS6072553
Single Lumen Central Venous Catheter Set
C-PMS-250-PED G04889 NS6168054, NS6178118
C-PMS-251J-PED G05345 NS6063352
C-PMS-300- CHILDRENS-032285 G02805 NS5855441
C-PMS-301J-PED G03117 5824486, 5898058, 5967405, 6079119, NS5932737, NS6028554, NS6042799
C-PMS-301J-PED-BH G06993 NS5922707, NS5932811
C-PMS-301-PED G02990 NS6145002
C-PUM-300J G02140 NS5970942
C-PUM-301 G02225 NS5954223
C-PUM-301J G02128 5945120, NS5954224
Single Lumen Central Venous Catheter Tray
C-PMSY-250 G02854 5987014
C-PMSY-251 G03241 NS6178099
C-PMSY-251J G05434 NS6028540
C-PMSY-300 G01926 NS5830758, NS5866960, NS5918174, NS5974263, NS6042577, NS6047450, NS6090278, NS6105922, NS6124990
C-PMSY-300J G01927 NS5881337, NS5892116, NS6031991
C-PMSY-300J-UT-A G06141 5782006, 5855241
C-PMSY-300-PED G12497 NS5881336, NS5892113, NS5945282
C-PMSY-301J G02244 6062729
C-PMSY-301J-BH G02570 NS5970950, NS6108255, NS6153173
C-PMSY-301J-PED G03433 5793198, 5925744, 6010406, 6148800
C-PMSY-301J-PED-OTP G10375 NS5796483, NS5928602
C-PMSY-400- HURLEY-022388 G04755 NS6047451
C-PUMY-301J G02157 5973354
Single Lumen Pressure Monitoring Set
C-PMS-250 G02838 6028502, 6034979, 6083984, 6194848, NS6014456, NS6014457
C-PMS-2502-15-3.5 G07943 6148788, 6254047
C-PMS-2502-15-5.0 G03425 5906417, 6160213
C-PMS-250- MONTES-A-092084 G03079 NS6064797
C-PMS-251 G02833 NS6014483, NS6175149, NS6184593, NS6187516
C-PMS-251J G02925 NS6014458
C-PMS-300 G01911 5889463, 5898283, 5922849, 5941909, 5964565, 5976506, 6021072, 6028497, 6143834, 6160238
C-PMS-300- CHILDRENS-A-032988 G04448 NS5933957
C-PMS-300J G01912 5828147, 5941919
C-PMS-301 G01961 NS5932835, NS5932836, NS6050233, NS6072523, NS6108227, NS6130497
C-PMS-301J G02061 5803601, 6034985, 6075213
C-PMS-301J-PKG G06296 NS5833882, NS5892109, NS5892110, NS5919920, NS6021136, NS6054843, NS6072524, NS6075557, NS6082375, NS6108228, NS6148658
C-PMS-400J G01914 6067668

Shipments were made globally to the following regions: Australia, Belgium, Brazil, Canada, Chile, Denmark, Dominican Republic, Finland, France, Germany, India, Israel, Italy, Jordan, Kuwait, Netherland, New Zealand, Panama, Puerto Rico, Spain, Switzerland, United Arab Emirates, United Kingdom, and United States of America.

Cook Medical notified its customers and distributors by recall notification letters in January. All customers and distributors should quarantine and discontinue use of all affected units and return the affected product to the company as soon as possible for credit.

Cook Medical notified the FDA and other global regulatory agencies of this action.

Consumers with questions may contact Cook Medical Customer Relations at 1-800-457-4500 or 1-812­339-2235, Monday through Friday, between 7:30 a.m. and 5:00 p.m. Eastern time or via email at FieldActionsNA@cookmedical.com.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, via regular mail or via fax. Complete and submit the report online at www.fda.gov/medwatch/report.htm or via regular mail or fax. Download the form at www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, and then complete and return to the address on the preaddressed form, or submit via fax to 1-800­FDA-0178.

Adverse events may also be reported to Cook Medical Customer Relations at 1-800-457-4500 or 1­812-339-2235, Monday through Friday, between 7:30 a.m. and 5:00 p.m. Eastern time or via email at CustomerRelationsNA@cookmedical.com.

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Product Photos

  • Arterial Pressure Monitoring Catheter

Page Last Updated: 02/10/2016
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