10 Percent Neutral Buffered Formalin by Richard-Allan Scientific: Class I Recall – May Contain Incorrect Concentration of Formalin

This is a reprint of an FDA Alert.

AUDIENCE: Risk Manager, Surgery, Emergency Medicine

ISSUE: Richard-Allan Scientific discovered defective products returned from several customers were found to have from 0 percent to 3 percent Formalin content instead of the required 10 percent. A too-low or too high concentration of Formalin will not properly preserve or can damage tissues.

BACKGROUND: This recall was initiated on September 17, 2014 and includes 10 percent Neutral Buffered Formalin manufactured on July 18, 2014 and distributed between July 18 – September 17, 2014. Richard-Allan Scientific sent an Urgent Medical Device Recall letter dated September 10, 2014 to all customers followed by a second letter dated October 3, 2014 with additional information.

RECOMMENDATION: Richard-Allan advises customers/users to:

• Immediately stop using the defective product.
• Upon identifying the defective lots, notify Richard-Allan Scientific of the quantity and the preferred disposal/return method.
• If the defective product is being disposed of, evidence of disposal is required to be sent to Richard-Allan Scientific.
• If the defective product has been used with no issues, notify Richard-Allan Scientific of the quantity that is unavailable for return or disposal.
• Immediately complete and return the acknowledgement form that is attached to the Urgent Medical Device Recall letter.

The firm sent a follow-up letter dated October 10, 2014 that recommended attending physicians of all patients that could be affected be contacted in order to determine if further testing is required for their patients.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[10/31/2014 – Recall Notice – FDA]