FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-1872-2013
- 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.
- Status
- Terminated
- Initiated
- 2013-07-10
- Posted
- 2013-08-02
- Terminated
- 2014-01-06
- 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 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
- 1,200 pens
- Distribution
- US Distribution including the states of SC, TX, TN, WA, OK.
- Lot, serial or model codes
- Part Number: PDC PN STE-VIS (Viscot PN 1437-100) Lot: 061313.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FZZ
- Firm FEI
- 2020282
- Firm city
- Valencia
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28