Z-1872-2013Class II

Non-sterile Viscot Surgical Skin Markers Part Number 1437-100 Non-sterile Viscot Part Number 143-100 Surgical...

Name: Z-1872-2013 Non-sterile Viscot Surgical Skin Markers Part Number 1437-100 Non-sterile Viscot Part Number 143-100 Surgical...
Creator: Precision Dynamics Corporation
Published: 2013-07-10
License: https://open.fda.gov/license/

Precision Dynamics Corporation / initiated 2013-07-10 / Terminated / root cause: labeling and UDI

FDA source

Precision Dynamics Corporation began a recall of 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... on 2013-07-10. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1872-2013
Classification: Class II
Status: Terminated
Initiated: 2013-07-10
Posted: 2013-08-02
Terminated: 2014-01-06
Recalling firm: Precision Dynamics Corporation
Product: 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.
Product code: FZZ Marker, Skin
Reason for recall: 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 tag: labeling and UDI
FDA 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 directly to arrange the return of the product. In addition, if you may have distributed this product, please identify your customers and notify them at once of this product recall. Your customer notification may be enhanced by including a copy of this recall notification letter. If you have any questions please call the PDC Healthcare Returns Department at 800-435-4242 ext. 5003. Thank you for your understanding and assistance related to this matter.
Quantity in commerce: 1,200 pens
Distribution: US Distribution including the states of SC, TX, TN, WA, OK.
Product codes and lots: Part Number: PDC PN STE-VIS (Viscot PN 1437-100) Lot: 061313.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1872-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1872-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-14	2013-08-02

Product code FZZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)