Reported Mar 16, 2016 · Terminated
Super Arrow-Flex Percutaneous Sheath Introducer Sets REF CL-07035 or CL-07635 or CL-07735 or CL-07835 Super Arrow-Flex…
Arrow International Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Arrow International Inc · 2400 Bernville Rd · Reading, PA · 19605-9607
Is this the product you have?
- Super Arrow-Flex Percutaneous Sheath Introducer Sets REF CL-07035 or CL-07635 or CL-07735 or CL-07835 Super Arrow-Flex Percutaneous Sheath Introducer Set with Integral Hemostasis Valve/Side Port
- and Radiopaque Tip Marker Band Contents1: . . . . . . . . . Sheath*: *** Super Arrow-Flex Radiopaque with Integral Hemostasis Valve/Side Port, 3-way
- Stopcock and Tissue Dilator 1—
- Obturator8 Fr. Rx only. The Arrow Percutaneous Sheath Introducer is intended for use in the hospital catheterization laboratory for the percutaneous introduction of various devices into veins and/or arteries in a variety of diagnostic and therapeutic procedures
- Lot codes and dates
- Material numberCL-07035 Batch #'s:Material #: CL-07635 Batch #'s:
CF0045142CF0087118CF0090127CF0128575CF1022799CF1034863CF1046302CF1060275CF1083652CF2019968CF2021329CF2045237CF2056298CF2092322CF2125658CF303107014F13G015714F13H014014F13K010814F13K033414F14A043514F14B029514F14C044914F14F018414F14F028214F14J005514F14L012614F15A009714F15A047314F15C045514F15C045514F15E008314F15E039214F15G035014F15L0009
Material #: CL-07735 Batch #'s:153 of 153 codes
CF0014629CF0016145CF0026765CF0027875CF0029004CF0031879CF0043747CF0044445CF0045312CF0046072CF0057307CF0058371CF0058639CF0059715CF0060443CF0061539CF0062000CF0062968CF0074416CF0074954CF0086388CF0088268CF0098848CF0099814CF0090135CF0090990CF0104732CF0115512CF0115640CF0117991CF0128581CF0129532CF1022803CF1022900CF1023194CF1035539CF1046005CF1046603CF1057461CF1058601CF1069026CF1069417CF1071115CF1071530CF1082816CF1083655CF1084050CF1094408CF1095121CF1095422CF1106140CF1106463CF1106567CF1106866CF1117776CF1118184CF2010024CF2010554CF2011013CF2021345
Material #: CL-07835 Batch #'s:98 of 98 codes
CF0016456CF0026767CF0027385CF0028486CF0031869CF0043766CF0045145CF0046070CF0057960CF0059633CF0060473CF0062110CF0063321CF0074956CF0087127CF0088323CF0090136CF0102551CF0104733CF0115515CF0117962CF0128881CF1010273CF1022804CF1023188CF1034955CF1035534CF1046237CF1057122CF1057847CF1069027CF1069422CF1060281CF1071533CF1084052CF1094634CF1105903CF1106857CF1118176CF1129218CF2010449CF2011017CF2032701CF2033764CF2044055CF2044562CF2055623CF2055885CF2067195CF2068127CF2078858CF2079277CF2079801CF2079894CF2080840CF2125806CF3017886CF3018109CF3028509CF3028705
86 of 86 codes
CF0014633CF0026778CF0028429CF0029002CF0043169CF0046789CF0058376CF0061314CF0062035CF0063323CF0086389CF0098907CF0090978CF0104735CF0128583CF1022800CF1023680CF1035526CF1046612CF1057118CF1058023CF1069009CF1069427CF1071067CF1082806CF1084066CF1094643CF1095413CF1106147CF1117143CF2010674CF2021578CF2022383CF2033430CF2044046CF2055624CF2056307CF2056890CF2067792CF2068581CF2079137CF2079794CF2079908CF2080524CF3016368CF3016852CF3018112CF3028508CF3029318CF3039885CF3031078CF3041826CF3042524CF3053165CF306513514F13G015514F13H012714F13H028814F13J003814F13K0175
- Material numberCL-07035 Batch #'s:
- Amount recalled
- 56,521 units
Where it was sold
Why it was recalled
Arrow has issued a recall for these products due to potential packaging damage. The sterility of the products cannot be guaranteed. If non-sterile product is used there is a potential for infection to occur.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Arrow International Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.