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Portex ProVent Arterial Blood Sampling Kit with Dry Lithium… recallZ-1716-2020 · Smiths Medical ASD, Inc. · initiated Jan 7, 2020

Class II Terminated All recalls posted in April 2020

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Smiths Medical ASD, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Lots of Smiths Medical Portex Pro-Vent and LineDraw Arterial Blood Sampling syringes may have broken luers.

FDA root cause category: Process control

What the company is doing

The firm initiated the recall by letter on January 07, 2020. The "Urgent Medical Device Recall Notice", identified the removal of devices and instructed the customer to quarantine the affected products. The Notice provided the accompanying Recall Response Form to be completed and returned within 10 days of receipt to [email protected]. The Notice details that the affected product must be returned to Stericycle for processing. The Notice instructed the distributor to notify their customers and to provide the customer a copy of the Recall Notice and Response Form. The Notice provided the contact email [email protected] and phone number of 8669188738 for assistance.

Recall details

Recall number
Z-1716-2020
Recall class
Class II
Status
Terminated
Initiated by the company
Jan 7, 2020
Posted by the FDA
Apr 15, 2020
Recalling firm
Smiths Medical ASD, Inc.
Quantity
127,700 total devices
Product code
JKA
FDA submissions
K952516
Distribution
USA: AL, AR, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, MI,MN, MO, MS, NC, NE, NJ, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA. Int'l: CA, DE, AU.

Product description

Portex ProVent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes

Code information (models, lots, serial numbers)

Portex Pro-Vent Arterial Blood Sampling Kit: Item Number Lot Number G1724 3859779 G1702 3863522 4599P-1 3859751 4599P-1 3862142 4599P-1 3863544 4599P-1 3863545 4599P-1 3869581 G1665 3856947 4588P-2 3862145 4558PE 3859727

Other devices under the same FDA submission

34 devices cleared under K952516 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 84681).

Sources and updates

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