Shandon Rapid Chrome Kwik-Diff Kit Part Number: 9990700 Shandon Rapid Chrome Kwik-Diff Reagent #3 Part Number 9990707 Sh

FDA device recall Z-1895-2017 · posted 2017-04-17 · Terminated

Recall details

Recalling firm

Richard-Allan Scientific Company

Reason for recall

Methylene Blue, Solution #3 in the Kwik Diff Kit was not Methylene Blue but Crystal Violet instead.

Action taken

On 3/15/2017, URGENT MEDICAL DEVICE RECALL letters were sent to the affected consignees. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. ACTIONS TO BE TAKEN BY THE CUSTOMER/USER Please contact Richard Allan Scientific for directions on safe disposal or return if customers have affected lots. All other lots of the products, or similar products manufactured by Richard Allan Scientific, are unaffected. Upon identification of the affected lot, please notify Richard Allan Scientific of the quantity and the preferred disposal/return method. If product is being disposed of, evidence of disposal is required to be sent to Richard Allan Scientific. If affected product has been used with no issues, please notify Richard Allan Scientific of the quantity that is unavailable for return or disposal. Please use the attached Recall Return Response Acknowledgement & Receipt Form.

Root cause

Mixed-up of materials/components

Status

Terminated

Product code

HYF

Quantity affected

390

Distribution

Worldwide Distribution -- US: CA, CO, CT, DE, GA, HI, IA, IL, KS, MA, MS, NC, NH, NM, NY, OH, PA, PR, RI, UT, VA, VT, WA, and WV; and, the countries of AE, BH, CA, CZ, FR, GB, HK, SA, and TR.

Date initiated

2017-03-15

Date posted

2017-04-17

Date terminated

2017-07-27

Location

Kalamazoo, MI