| Date Initiated by Firm |
May 15, 2013 |
| Date Posted |
July 10, 2013 |
| Recall Status1 |
Terminated 3 on June 16, 2015 |
| Recall Number |
Z-1684-2013 |
| Recall Event ID |
65183 |
| 510(K)Number |
K960787
|
| Product Classification |
System, irrigation, urological - Product Code LJH
|
| Product |
Four Lead Arthroscopic Irrigation Set, for use with ARTHROMATIC Plastic Containers, Product Code 2C4031 -Approximate Length 99" (2.5. m)
Usage:
Baxter irrigation sets are intended for the delivery of irrigating solutions from the fluid container to the irrigation site during bladder irrigation or endoscopic procedures including cytoscopy, transurethral resection and arthroscopic procedures. the sets are intended for use with Baxter irrigating solutions in Uromatic or Arthromatic plastic containers.
|
| Code Information |
R08D28039 R08D28047 R08D28054 R08H20094 R08H22124 R08H25010 R08H28113 R08I06083 R08I08097 R08I09087 R08J06124 R08J13088 R08K21139 R08K29074 R08L08092 R08L12110 R09A16013 R09A27101 R09A31079 R09B17043 R09B26010 R09C02084 R09C15029 R09D13089 R09E12120 R09E19133 R09F13068 R09F22028 R09G13108 R09H05037 R09H06134 R09H19111 R09I08096 R09I27013 R09J08038 R09J14010 R09J27103 R09J28119 R09K12129 R09L04017 R09L22035 R10A06011 R10A08165 R10A19113 R10A21655 R10B17024 R10C11033 R10C11116 R10C15026 R10D15081 R10D16063 R10D16154 R10D24067 R10E03035 R10G21108 R10G27089 R10H21064 R10H23110 R10I02138 R10I04068 R10I25071 R10J19123 R10J25096 R10K17984 R10K25094 R10L03065 R10L06019 R10L21174 R11B16165 R11B23161 R11C15165 R11C22229 R11D04084 R11D12038 R11E04115 R11E13066 R11E28072 R11E30086 R11F08171 R11H05041 R11H16071 R11H22053 R11I06039 R11I16095 R11I28249 R11J12093 R11J13158 R11J14081 R11K19054 R11K21183 R12A09070 R12A09112 R12B25058 R12C28142 R12E19070 R12E21076 R12E31125 R12F11109 R12F12081 |
Recalling Firm/
Manufacturer |
Baxter Healthcare Corp.
1 Baxter Pkwy
Deerfield IL 60015-4625
|
| For Additional Information Contact |
Center for One Baxter
800-422-9837
|
Manufacturer Reason
for Recall |
A firm's internal investigation led to the discovery of pinholes in the packaging of the products. The pinholes are not likely to be detected by the end user prior to use and could compromise the sterile barrier properties of the packaging.
|
FDA Determined
Cause 2 |
Packaging |
| Action |
Baxter sent an Urgent Product Recall letter dated May 15, 2013 to all affected custorners. The letter identified the affected product, problem and actions to be taken. Customers were requested to remove all affected products and return for credit by contacting Baxter Healthcare Center for Service at 888-229-0001. Customers were instructed to complete the attached Customer Reply Form and return it to Baxter by either faxing to 224-270-5457 or scanning and e-mailing the reply form to fca@baxter.com |
| Quantity in Commerce |
249,576 units |
| Distribution |
US Nationwide Distribution |
| 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.
|
| 510(K) Database |
510(K)s with Product Code = LJH and Original Applicant = BAXTER HEALTHCARE CORP.
|
