Medrad(R) Sterile Disposable Stellant Syringe Kit, Catalog # SDS-CTP-SPK, Lot # 112865. Angiographic syringe intended to

FDA device recall Z-0147-2012 · posted 2011-11-02 · Terminated

Recall details

Recalling firm

Medrad Inc

Reason for recall

Packaging may exhibit open seals - sterility compromised

Action taken

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.

Root cause

Packaging

Status

Terminated

Product code

DXT

Quantity affected

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,

Date initiated

2011-10-24

Date posted

2011-11-02

Date terminated

2016-10-24

Location

Indianola, PA

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