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Recall Observatory FDA recall evidence

Device product

ProtectIV¿ Plus Safety IV Catheter, sterile. Packaged in a pouch and than into an inner carton.

Z-0352-2020

November 26, 2018

Class II

Product summary

Firm
Smiths Medical ASD Inc.
Event
Event 81708
Status
Terminated
Classification
Class II
Quantity
219,150 devices
Official record key
device-enforcement:Z-0352-2020

Official wording

Reason: Certain lots of the Model 306701 ProtectIV¿ Plus Safety IV Catheter may exhibit damage on the safety mechanism guard.

Code information: Model number 306701; Lot numbers: 3635765, 3639446, 3642834, 3646828, 3646829, 3646830, 3646831, 3646832, 3646833, 3651082.

Distribution pattern: United States - AK, AZ, FL, GA, IL, IN, KS, LA, MD, MN, MS, NC, NJ, NY, OH, PA, SC, TN, TX, VA, and WA. One foeign consignee in Costa Rica

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Certain lots of the Model 306701 ProtectIV¿ Plus Safety IV Catheter may exhibit damage on the safety mechanism guard.