Recall Z-0262-2012 ยท KOY Degreaser, Skin, Surgical
Del Mar Reynolds Medical, Ltd.
PDI Electrode Prep Pads, Skin Prep B339 are non-sterile alcohol prep pads. They are included in the Spacelabs Healthcare Hook-Up kits. Each kit contains 2-4 pieces of PDI Electrode Prep Pads . Hook-up kits that contain the affected alcohol prep pads are as follows: Aria, Kit Part number 23189-010, Kit, Basic hookup, AA; CardioCall, Kit Part number 23189-020, Kit, Hookup, CardioCall; Aria, Ki
| Date | Nov 21, 2011 (initiated Oct 12, 2011) |
| Status | Terminated |
| Reason | 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). |
| Root cause | Material/Component Contamination |
| Action | 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. |
| Quantity | 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 Korea, Argentina, Thailand, Italy, Austria, Chile, Bolivia, Mexico, Sweden, Netherlands, Switzerlan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.