Recall Z-2749-2015
Elcam Medical, Inc. · initiated July 19, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Elcam Medical MANI 3G Plate BLS RAD B.BRAUN; Manifold for pressure monitoring and intravenous fluid administration. Manufactured by: Elcam Medical ACAL, Israel; Distributed by: Elcam Medical Inc., USA. Sterile
Codes / lots: Elcam Part Number: 470306; lot numbers: 1370256602, 1370263901, 370263902, 1370271301, 1370274101, 1470288601, 1470288602, 1470298801, 1470306701, 1470312401 Elcam Part Number: 470307; lot numbers: 1370254802, 1370266801, 370271401, 1370282101, 1470288701, 1470293001, 1470295901 Elcam Part Number: 471601; lot numbers: 1270239001, 1370266601, 1370271501, 1370278801 Elcam Part Number: 471604; lot numbers: 147029310, 1470306801, 1470310201, 1470312501 Elcam Part Number: 477101; lot numbers: 1270244201, 1370278901, 1470292401, 1470292402, 1470298901, 1470301301, 1470306901, 1470310101, 1470312601 Elcam Part Number: 477102; lot numbers: 1370261201, 1570323201 Elcam Part Number: 477901; lot number: 1370255601 Elcam Part Number: 477904; lot number: 1470300101 Elcam Part Number: 478003; lot numbers: 1370261401, 1370266701, 1370271701, 1370271702, 1370278601, 1370278602, 1470293201, 1470296001, 1470307001, 1470312701, 1570316201 Elcam Part Number: 478004; lot numbers: 1370255001, 1370261501, 1370271801, 1370279001, 1470296101, 1470297801, 1470303801, 1470307101, 1470312801 Elcam Part Number: 478701; lot numbers: 1270244901, 1370261301, 1370271901 Elcam Part Number: 478704; lot numbers:…
Reason for recall
Punctured blister packages were detected during the packaging process at the manufacturing site. Potential for device contamination.
FDA-determined cause: Packaging
Action taken
Elcam Medical sent "Urgent: Stopcock Recall" notices and "Recall Return Response Forms" dated 7/19/2015 to their customers. The recall notification informed the customers of the reason for the recall and the actions they must take. Customers were instructed to cease distribution and quarantine any affected products; return to Elcam Medical the enclosed Recall Return Response Form; and notify their customers as per their recall procedures.
Details
- Recall number
- Z-2749-2015
- Initiated
- July 19, 2015
- Posted by FDA
- September 10, 2015
- Terminated
- September 18, 2017
- Product code
- LZG – Pump, Infusion, Insulin
- Quantity
- 248,100
- Distribution
- Texas, New Mexico and Pennsylvania
- Recalling firm
- Elcam Medical, Inc., Hackensack, NJ
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2748-2015 Class II | Elcam Medical Minimal Residual Volume Luer activated Swabbable stopcock (MRVLS) for…Punctured blister packages were detected during the packaging process at the manufacturing site. Potential… | 07/19/2015Terminated |