PRODUCT RECALL Sage Oral Care Products Moisturizers (Distributed by Cardinal Health)

Transcription

1 Ref: 2017SEP05-P-SAG 2017 September 05 Recall ZONES/Sites Clinical Areas Affected NORTH ZONE EDMONTON ZONE CENTRAL ZONE CALGARY ZONE SOUTH ZONE ALL Hospital, Community Care and Long Term Care Sites ALL Clinical Areas Important information for medical device users ISSUE SAGE6083 PRODUCT RECALL Oral Care s Moisturizers (Distributed by ) is recalling certain lots of two Oral Care Moisturizers (listed below), due to a failure of the third party manufacturer to comply with good manufacturing processes leading to the potential for cross contamination from equipment shared with non-pharmaceutical products. There has been no confirmed cross-contamination nor any reports of patient effects attributable to this potential problem. Alternate products (as below) have been sourced from McKesson Canada and are currently available from warehouses/inventories. Note: This recall is in addition to the recall of other Oral s Suction, EP Advisory 31 August Affected s Suggested Alternates Code Description Lot # Description Supplier Item Moisturizer, Mouth Moisturizer Mouth Gel See Vendor 0.5 Oz 1.5 Oz Biotene Notice, Spray 27.5 ml Mouth Spray Mouth Moisturizer SAGE5210 Attached Moisturizer Spearmint 44 ml Biotene ACTION Review your stock on hand for affected product and isolate. Work with your appropriate contact for returns: Inventory users work with your Site Services contact for the return and replacement of affected product. Direct Purchase users - work with your Procurement contact for the return of affected product and to order alternate product as required. Complete and send the Customer Reply Form (vendor notice, p. 3-4, attached) to fca.canada@cardinalhealth.ca or fax to For inventory users warehouses/inventories will complete the form on your behalf when the affected product is returned. Complete and return the E&P Advisory Response Form (attached) to ep.advisory@albertahealthservices.ca or fax# If you are not a user of these products, no response is required. Contact: Caren Keeling, RN, BScN, Clinical Safety Coordinator, Safety caren.keeling@ahs.ca Phone: For, Covenant Health, and subsidiaries use only. Do not distribute outside these organizations.

2 Canada 2200 Rue l Aviation Dorval, QC H9P 0A3 August 22, These Safety. Code URGENT RECALL Oral Care s Canada Code 5210 SAGE5210 Dear Valued Customer, Affected lot numbers 51035, 51355, 52218, 52786, 53841, 54041, 54808, 56331, 56978, 57409, 58827, 59455, 60808, 60855, , 51467, 52096, 52499, 52769, 53036, 53634, 53732, 54088, 54621, 54779, 55200, 55696, 55956, 56497, 56951, 57684, 58242, 58706, 59081, 59633, 59776, 60315, 61053, SAGE6083 * 6714 SAGE , 58845, 60215, * 6013-C SAGE6013-C 54951, 56657, 57256, 58584, 59632, 60501, These 12 * 6306-C SAGE6306-C 59736, items * 6424-C SAGE6424-C 60287, * 6434-C SAGE6434-C 58988, 60228, C SAGE6512-C 54961, 55818, 56919, 58145, * 55145, 55923, 56345, 57136, 58147, 59832, 60848, * 6513-C SAGE6513-C 61558, 61564, Provinical * 6552-C SAGE6552-C 55873, 57263, 58374, 60584, * 6570-C SAGE6570-C 56161, 58565, 59615, , 55280, 56097, 57831, 57845, 58572, 59472, * 6572-C SAGE6572-C 60681, 61322, * 6808-C SAGE6808C 54843, 56011, 58471, 60071, Safety. * 6924-C SAGE6924-C 55382, 56031, 56728, 57461, 58484, 60235, Canada has been informed that is initiating an Urgent Recall of the above-mentioned products. For more information, please read the letter from. Our records indicate that we have distributed the above - mentioned products to your facility. Immediately inspect your stock for the product mentioned above, and quarantine any affected products. If you are a distributor, please conduct a sub-recall of the affected SAGE products using the enclosed SAGE letter. (Version française disponible sur demande) Page 1 of 2

3 Canada 2200 Rue l Aviation Dorval, QC H9P 0A3 Complete and fax or back the Customer Reply form to fax or fca.canada@cardinalhealth.ca in order to confirm your receipt of this recall letter by September , even if you have no affected stock. This will avoid receiving a second notification. Instructions for Credit and Return: Upon receipt of your completed customer reply form, if you have affected stock, our CUSTOMER CARE representative will contact you to arrange for product return and credit of any unused/unopened affected stock. Please do not contact Customer Care directly for credit as we need to process your regulatory response prior to issuing credits. With any product return a copy of the Customer Reply Form MUST BE INCLUDED. For all matters regarding this recall, you must respond to Canada directly. If you are distributor, please complete a sub recall We regret the inconvenience caused by this action and thank you for your prompt response. You can contact me by at fca.canada@cardinalhealth.ca, should you have any questions. Sincerely, Scott Hayden Specialist, Quality Assurance Canada Encl: Customer Reply Form letter dated August 2017 (Version française disponible sur demande) Page 2 of 2

4 CUSTOMER REPLY FORM URGENT RECALL *** A RESPONSE IS REQUIRED BY SEPTEMBER 08, 2017*** Oral Care s We have no inventory within the scope of this recall. We have the following affected products at our facility and have discontinued use and distribution. We have quarantined the affected products, and will return the following quantities (Please circle the Affected Lot Numbers being returned). The lower 12 items Safety Code Canada Code 5210 SAGE SAGE SAGE6714 Affected Lot Numbers 51035, 51355, 52218, 52786, 53841, 54041, 54808, 56331, 56978, 57409, 58827, 59455, 60808, 60855, , 51467, 52096, 52499, 52769, 53036, 53634, 53732, 54088, 54621, 54779, 55200, 55696, 55956, 56497, 56951, 57684, 58242, 58706, 59081, 59633, 59776, 60315, 61053, , 58845, 60215, , 56657, 57256, 58584, 59632, 60501, C SAGE6013-C 6306-C SAGE6306-C 59736, C SAGE6424-C 60287, C SAGE6434-C 58988, 60228, C SAGE6512-C 6513-C SAGE6513-C 6552-C SAGE6552-C 54961, 55818, 56919, 58145, , 55923, 56345, 57136, 58147, 59832, 60848, 61558, 61564, , 57263, 58374, 60584, Total # of Units on Hand to return (EA) Page 1 of 2 The lower on the list

5 The lower on the list August 31. Safety Code Canada Code 6570-C SAGE6570-C 6572-C SAGE6572-C 6808-C SAGE6808C 6924-C SAGE6924-C Affected Lot Numbers 56161, 58565, 59615, , 55280, 56097, 57831, 57845, 58572, 59472, 60681, 61322, , 56011, 58471, 60071, , 56031, 56728, 57461, 58484, 60235, Please Complete your Customer information: Total # of Units on Hand to return (EA) The lower on the list communic ated Hospital or Facility Name: Customer Number: Address: City: Prov: Postal Code: Name: (Please Print): Title: Phone #: Fax #: Please send your responses by: at fca.canada@cardinalhealth.ca Fax to Page 2 of 2