SUBCLAVIAN PROCEDURE TRAY
This recall has been terminated (originally issued April 22, 2003).
- Company
- Windstone Medical, Inc.
- Recall Initiated
- March 25, 2003
- Posted
- April 22, 2003
- Terminated
- September 9, 2003
- Recall Number
- Z-0772-03
- Quantity
- 3500
- Firm Location
- North Billings, MT
- Official Source
- View on FDA website ↗
Reason for Recall
Product contains latex, but not labeled as containing latex.
Distribution
The firm distributed to 13 hospitals and medical facilities located in CO, IN, MI, MN, MT, UT, and WA.
Lot / Code Info
Catalog Number CPA-1069 Lot Numbers 000000668, 000000669, 000000670, 000000672, 000000673, 000000674, 000000676, 000000677, 000000671, 000000675, 000000678, 000000679, 000000681, 000000682, 000000683, 000000684, 000000692, 000000693, 000000694, 000000695, 000000696, 000000697, 000000698, 000000699, 000000709, 000000713, 000000716, 000000717, 000000720, 000000724, 000000725, 000000728, 000000732, 000000733, 000000734, 000000735, 000000736, 000000737, 000000680, 000000685, 000000686, 000000687, 000000688, 000000689, 000000690, 000000691, 000000700, 000000701, 000000702, 000000703, 000000704, 000000705, 000000706, 000000707, 000000708, 000000710, 000000711, 000000712, 000000714, 000000715, 000000718, 000000719, 000000721, 000000722, 000000723, 000000726, 000000727, 000000729, 000000730, 000000731, 000005001, 000005002, 000005003, 000005004, 000005005, 000005006, 000005007, 000005008, 000005009, 000005010, 000005014, 000005015, 000005016, 000005021, 000005022, 000005025, 000005026, 000005027, 000005029, 000005030, 000005031, 000005032, 000005011, 000005012, 000005013, 000005017, 000005018, 000005019, 000005020, 000005023, 000005024, 000005028, 000005033, 000005034, 000005035
Root Cause
Other
Action Taken
On 3/25/03 the firm contacted their customers by telephone. This was followed by a letter dated 3/25/03. Enclosed with the letter is a response form for the customer to fill out and return to the firm. Product is to be returned to the firm.