Single Lumen Central Venous Catheter Sets and Trays The recall
Single Lumen Central Venous Catheter Sets and Trays The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated catheter.…
Why was Single Lumen Central Venous Catheter Sets and Trays The recalled?
A manufacturing process may lead to catheter tip fracture and or separation. Potential adverse events may include loss of device function, medical intervention to retrieve a separated segment, or complications resulting from a separated tip occluding blood flow to end organs. These catheters are used in venous or arterial pressure monitoring, blood sampling, and administration of drugs and fluids.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
RPN/Catalog number: C-PMS-250-PED C-PMS-251J-PED C-PMS-300-CHILDRENS-032285 C-PMS-301J-PED C-PMS-301J-PED-BH C-PMS-301-PED C-PMSY-250 C-PMSY-251 C-PMSY-251J C-PMSY-300 C-PMSY-300J C-PMSY-300J-UT-A C-PMSY-300-PED C-PMSY-301J C-PMSY-301J-BH C-PMSY-301J-PED C-PMSY-301J-PED-OTP C-PMSY-400-HURLEY-022388 C-PUM-300J C-PUM-301 C-PUM-301J C-PUMY-301J Lots: NS6168054 NS6178118 NS6063352 NS5855441 5824486 5898058 5967405 6079119 NS5932737 NS6028554 NS6042799 NS5922707 NS5932811 NS6145002 5987014 NS6178099 NS6028540 NS5830758 NS5866960 NS5918174 NS5974263 NS6042577 NS6047450 NS6090278 NS6105922 NS6124990 NS5881337 NS5892116 NS6031991 5782006 5855241 NS5881336 NS5892113 NS5945282 6062729 NS5970950 NS6108255 NS6153173 5793198 5925744 6010406 6148800 NS5796483 NS5928602 NS6047451 NS5970942 NS5954223 5945120 NS5954224 5973354
- Product
- Single Lumen Central Venous Catheter Sets and Trays The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated catheter.…
- Recalling firm
- Cook Inc.
- Quantity
- 1341
- Distribution
- Worldwide Distribution - US Nationwide including DC and PR including the countries of Australia, Germany, China, Chile, Dominican Republic, Panama, Israel, Brazil, Canada
- Recall date
- March 2, 2016
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)