Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Spacelabs Healthcare HookUp kits

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Spacelabs Healthcare HookUp kits see related information
Date Initiated by Firm October 12, 2011
Date Posted November 21, 2011
Recall Status1 Terminated 3 on February 23, 2012
Recall Number Z-0262-2012
Recall Event ID 60205
Product Classification Degreaser, skin, surgical - Product Code KOY
Product 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, Kit Part number 23189-106, Kit, Aria Hookup;
Aria, Kit Part number 23189-110, Kit, Aria Hookup;
Flashcorder, Kit Part number 23189-111, Kit, Flashcorder Hookup;
Aria, Kit Part number 23189-113, Holter Hookup Kit 7 electrode;
LifeCard 12, Kit Part number 23189-114, Kit, Hookup, LC12, Multilingual;
Aria, Kit Part number 23189-115, Kit, Basic Hookup, AAA;
LifeCard, Kit Part number 23189-116, Kit, Holter Hookup, LifeCard;
483, Kit Part number 23189-117, Kit, Holter Hookup 483;
Aria, Kit Part number 23189-153, Holter Hookup Kit, 7 electrode;
Aria VLC, Kit Part number 23189-207, Kit, Aria Hookup, VLC;
EVO, Kit Part number 50-0048, 4 electrode hookup kit without pouch;
EVO, Kit Part number 50-0049, 4 electrode hookup kit with pouch;
EVO, Kit Part number SK10456, Sample Kit, Disposables.

A surgical skin degreaser or an adhesive tape solvent is a device that consists of a liquid such as 1,1,2-trichloro-1,2,2-trifluoroethane; 1,1,1-trichloroethane; and 1,1,1-trichloroethane with mineral spirits intended to be used to dissolve surface skin oil or adhesive tape.
Code Information B339 is listed on the PDI Alcohol 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, Kit Part number 23189-106, Kit, Aria Hookup; Aria, Kit Part number 23189-110, Kit, Aria Hookup; Flashcorder, Kit Part number 23189-111, Kit, Flashcorder Hookup; Aria, Kit Part number 23189-113, Holter Hookup Kit 7 electrode; LifeCard 12, Kit Part number 23189-114, Kit, Hookup, LC12, Multilingual; Aria, Kit Part number 23189-115, Kit, Basic Hookup, AAA; LifeCard, Kit Part number 23189-116, Kit, Holter Hookup, LifeCard; 483, Kit Part number 23189-117, Kit, Holter Hookup 483; Aria, Kit Part number 23189-153, Holter Hookup Kit, 7 electrode; Aria VLC, Kit Part number 23189-207, Kit, Aria Hookup, VLC; EVO, Kit Part number 50-0048, 4 electrode hookup kit without pouch; EVO, Kit Part number 50-0049, 4 electrode hookup kit with pouch; EVO, Kit Part number SK10456, Sample Kit, Disposables.
Recalling Firm/
Manufacturer		 Del Mar Reynolds Medical, Ltd.
1-2 Harforde Ct., Foxholes
Business Park
Hertford United Kingdom
Manufacturer 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).
FDA Determined
Cause 2		 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 in Commerce 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, Switzerland, India, Serbia, Australia, Morocco, Turkey, ISpain, Czech Republic, Slovakia, Poland, China, Columbia, Portugal, Canada, Germany, United Kingdom, Singapore, France, Russian Federation, Bahrain, and Kuwait
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
-
-