Jackson-Pratt Wound Drainage Systems (2017-04-26)

Starting date:

April 26, 2017

Posting date:

May 31, 2017

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-63404

• Reason
• Affected products

Affected Products

1. Jackson-Pratt Silicone Flat Drains W/Wo Trocars
2. Jackson-Pratt Silicone Round Drains W/Wo Trocars
3. Jackson-Pratt Pvc Round Drains With Attached Trocar

Reason

Cardinal Health has become aware of a potential breach of sterility in the packaging of certain Jackson-Pratt perforated and Hemaduct wound drainage systems. In a small percentage of product (approximately 1.6%), the inner packaging (polybag) is caught in the seal area of the outer Tyvek pouch, potentially compromising the sterility of the package contents. While sterility is only impacted if the polybag fully breaches the seal (approximately 0.23% of product), as a precautionary measure, cardinal health is taking this action to ensure that product is not used if any portion of the polybag is caught in the seal area. Use of impacted products could result in an increased risk of infection.

Affected products