Recall Z-2589-2010
Organogenesis, Inc. · initiated August 2, 2010
Product
Apligraf is supplied as a living, bi-layered skin substitute. Article Number: GS100 Indicated for use with standard therapeutic compression for the treatment of non-infected partial and full-thickness skin ulcers due to venous insufficiency of greater than 1 month duration and which have not adequately responded to conventional ulcer therapy.
Codes / lots: Lot # GS1007.06.03.1A Unit numbers: 146-, 148, 149, 150, 151, 152, 154, 155, 157, 158, 159, 160, 162, 163, 172, 173, 174, 175, 176, 177, 178, 180, 181, 182, 184, 185, 186, 187, 188, 189, and 190.
Reason for recall
Product is contaminated with a yeast identified as Pseudozyma antarctica.
FDA-determined cause: Process control
Action taken
Organogenesis notified accounts by telephone, e-mail or fax on 8/2/010 to remove from use and return recalled units. If unit was applied to patient then monitor for adverse events. The Notification Letter dated August 6, 2010, described the issue and provided instructions for customers. Customers are to place the affected unit on hold for its return to the firm. The firm will contact customers to make arrangements for its return. Replacements have already been sent. If the affected unit has already been applied, the patients should be monitored closely for any potential adverse events. An Organogenesis Medical Affairs rep will be in contact regarding patient follow up. Customers are to complete the attached form and fax it back to the number provided. Questions should be directed to the Medical Information Center at 1-888-432-5232.
Details
- Recall number
- Z-2589-2010
- Initiated
- August 2, 2010
- Posted by FDA
- September 28, 2010
- Terminated
- March 10, 2011
- Product code
- MGR – Dressing, Wound And Burn, Interactive
- Quantity
- 32 units
- Distribution
- Nationwide Distribution -- AL, AZ, CA, CO, IL NC, PA, TN, and VA.
- Recalling firm
- Organogenesis, Inc., Canton, MA