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Medrad(R) Sterile Disposable Stellant Syringe Kit, Catalog… recallZ-0147-2012 · Medrad Inc · initiated Oct 24, 2011

Terminated All recalls posted in November 2011

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 Medrad 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

Packaging may exhibit open seals - sterility compromised

FDA root cause category: Packaging

What the company is doing

Medrad sent a " Urgent Medical Device Recall letter" dated October 24, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The customer was instructed if they have any of the affected product lot, please contact MEDRAD customer support to make arrangements for the return of the product. Call 1 -800-633-7231, select option 5, then select option 1. Indicate that you are calling about the affected syringe kit recall. Complete and sign the attached response form and fax it back to MEDRAD at (412) 406-0942. Please complete and fax this form even if you do not have any of the referenced product so we can maintain proper accountability for all syring kits that have been shipped.

Recall details

Recall number
Z-0147-2012
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Oct 24, 2011
Posted by the FDA
Nov 2, 2011
Recalling firm
Medrad Inc
Quantity
17,380
Product code
DXT
FDA submissions
K023183
Distribution
Nationwide Distribution -- including the States of : AL, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, VS, WA, WV, and WI.

Product description

Medrad(R) Sterile Disposable Stellant Syringe Kit, Catalog # SDS-CTP-SPK, Lot # 112865. Angiographic syringe intended to be used for the specific purpose of injecting intravenous contrast media into humans for diagnostic studies in computed tomagraphy.

Code information (models, lots, serial numbers)

Catalog # SDS-CTP-SPK, Lot # 112865

Other devices under the same FDA submission

15 devices cleared under K023183 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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