| | Class 2 Recall
Medrad(R) Sterile Disposable Stellant Syringe Kit |  |
| Date Posted |
November 02, 2011 |
| Recall Number |
Z-0147-2012 |
| Product |
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 |
Catalog # SDS-CTP-SPK, Lot # 112865
|
Recalling Firm/
Manufacturer |
Medrad Inc
1 Medrad Dr
Indianola, Pennsylvania 15051-9759 |
| For Additional Information Contact |
Kristi Carrico
724-940-6910
|
Reason for
Recall |
Packaging may exhibit open seals - sterility compromised
|
| Action |
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. |
| Quantity in Commerce |
17,380 |
| 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. |
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