Recall Z-1872-2013 ยท FZZ Marker, Skin
Precision Dynamics Corporation
Non-sterile Viscot Surgical Skin Markers Part Number 1437-100 Non-sterile Viscot Part Number 143-100 Surgical Skin Markers are pen-like devices intended to be used to write on the patient's skin, e.g., to outline surgical incision sites or mark anatomical sites for accurate blood pressure measurement; available in nonsterile configuration.
| Date | Aug 2, 2013 (initiated Jul 10, 2013) |
| Status | Terminated |
| Reason | PDC Healthcare initiated this recall of Non-Sterile Viscot Part Number 1437-100 Surgical Skin Markers, becuase they were inadvertently mislabeled as PN STER-VIS Sterile Skin Marker Pen with Labels and Flex Ruter. |
| Root cause | Component change control |
| Action | Precision Dynamics Corp. (PDC) sent a Urgent: Skin Marker Pen Recall letter dated July 10, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. All affected customers have also been contacted by phone and email as of July 12, 2013 We want to take every precaution to ensure patient safety. 1. Immediately examine your inventory 2. Quarantine the product subject to recall 3. Complete and return the enclosed response form as soon as possible Your PDC Healthcare customer service representative will contact you directl |
| Quantity | 1,200 pens |
| Distribution | US Distribution including the states of SC, TX, TN, WA, OK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.