Various Medline/Busse Surgical Instruments (2017-11-02)

Starting date:

November 2, 2017

Posting date:

November 24, 2017

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

Hospitals, Healthcare Professionals, General Public

Identification number:

RA-65158

• Reason
• Affected products

Affected products

A. DELUXE WOUND CLOSURE INSTRUMENT PACK
B. INCISION & DRAINAGE INSTRUMENT PACK
C. SUTURE REMOVAL KIT
D. CUSTOM GENERAL SURGERY PROCEDURE KIT/TRAY
E. I.V. START KITS

Reason

Medline reports that during routine review of stability samples, results demonstrated the product did not meet the iodine estimate levels required to support 36 months expiration dating. Aplicare has determined that the product(s) will instead support a 24 months expiration period. Therefore Busse has updated the expiration dates of the kits manufactured by Busse that were affected by the Aplicare expiration date revision.

Affected products