Devices

18 gage XTW needles

Model / Serial
Lot numbers S25589, S25590, S25756, S25769, S25787, S25909, S25910X1, S25911, S25924, S25948, S25949, S25950, S25951, S25972, S25973, S25974, S25975, S25996, S25997, S25998, S26001, S26002, S26003, S26009, S26010, S26011, S26012, S26039,S26040, S26044, S26045, S26058, S26059, S26060, S26063, S26064,S26088, S26089, S26092, S26095, S26102, S26146, S26177, S26178, S26182, S26183, S26198, S26203, S26214, S26217, S26218, S26230, and S26345.
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide distribution via distributors in CA, MA, and MN.
Product Description
18 gage XTW needles, sold as a component in SafeSheath Hemostatic Tear-away Introducer System with Infusion Side Port kits or sold Bulk Non Sterile (BNS).
Manufacturer
Thomas Medical Products Inc
1 Event
- Recall of 18 gage XTW needles

Manufacturer

Thomas Medical Products Inc

Manufacturer Address
Thomas Medical Products Inc, 65 Great Valley Pkwy, Malvern PA 19355-1302
Source
USFDA

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