Recall Z-1064-2016— Arrow International Inc
Class II · Terminated
Class II FDA medical device recall by Arrow International Inc, initiated 2016-01-12, terminated 2018-02-26. It names one FDA 510(k) clearance: K924607. Product: 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 Contents: 1: . . . . . . . . . Sheath*: *** Super Arrow-Flex Radiopaque with Integral Hemostasis Valve/Side Port, 3-way Stopcock and Tissue Dilator 1: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Obturator: 8 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.. Reason: 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..
- Recalling firm
- Arrow International Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-01-12
- Terminated
- 2018-02-26
- Firm location
- Reading, PA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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 Contents: 1: . . . . . . . . . Sheath*: *** Super Arrow-Flex Radiopaque with Integral Hemostasis Valve/Side Port, 3-way Stopcock and Tissue Dilator 1: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Obturator: 8 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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.