PDI Electrode Prep Pads, Skin Prep B339 are non-sterile alcohol prep pads. They are included in the Spacelabs Healthcare

FDA device recall Z-0262-2012 · posted 2011-11-21 · Terminated

Recall details

Recalling firm

Del Mar Reynolds Medical, Ltd.

Reason for recall

The non-sterile alcohol prep pads (B339) are included in Spacelabs Healthcare hook-up kits may have the presence of a bacterium, Bacillus cereus. These alcohol prep pads were manufactured and recalled by Professional Disposables International (PDI).

Action taken

SpaceLabs Healthcare sent an URGENT MEDICAL DEVICE CORRECTION letter dated October 21, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately stop using the affected product and dispose of them per their hospital or clinic protocol. For questions contact Spacelabs Healthcare at 1-800-522-7025 and select 2 for Technical Support.

Root cause

Material/Component Contamination

Status

Terminated

Product code

KOY

Quantity affected

25,000 pieces of PDI alcohol prep pads-15 different Spacelabs hook-up kits

Distribution

Worldwide Distribution - USA (natiowide) and the countries of South Africa, Turkey, Bangladesh, Dominican Republic, Peru, Belgium, Ecuador, Romania, Austria, Honduras, Guatemala, Denmark, Republic of

Date initiated

2011-10-12

Date posted

2011-11-21

Date terminated

2012-02-23

Location

Hertford, United Kingdom