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Class 2 Device Recall Pall |
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| Date Initiated by Firm |
February 21, 2005 |
| Date Posted |
April 27, 2005 |
| Recall Status1 |
Terminated 3 on December 20, 2006 |
| Recall Number |
Z-0765-05 |
| Recall Event ID |
31451 |
| Product Classification |
Circuit, Breathing (W Connector, Adaptor, Y Piece) - Product Code CAI
|
| Product |
Circuit- Matching Kit, 40'' Adult, 3L LPF, single use, Part Numbers RP640F0D0 and RP660F0D0. Manufactured for Pall Life Sciences, Ann Arbor, Michigan. Made in Mexico. |
| Code Information |
Part Number RP640F0D0, 20 per case, Lot Numbers: 575951104, 596600105; Part Number RP660F0D0, 20 per case, Lot Number: 596610105 |
Recalling Firm/
Manufacturer |
MMS Sales Corp
218 Highline Rd
Pharr TX 78577-9726
|
Manufacturer Reason
for Recall |
Partial occlusion in the T-piece resulting in airway obstruction.
|
FDA Determined
Cause 2 |
Other |
| Action |
The firm initiated the recall on February 21, 2004 by letter to all consignees. |
| Quantity in Commerce |
Total for all products: 7455 cases (161,273 units) |
| Distribution |
Product was distributed domestically to customers in CA, AZ, IL, CO, OR, FL, VA, OH, MI, and UT. Product was also distributed to the following foreign countries: Malaysia, Mexico, and New Zealand |
| Total Product Life Cycle |
TPLC Device Report
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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.
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