Device recall: Elcam Medical Minimal Residual Volume Luer activated Swabbable stopcock (MRVLS) for pressure monitoring and intravenous
FDA enforcement event 71880 is a device recall by Elcam Medical, Inc. of Hackensack, NJ, initiated 19 Jul 2015 and classified Class II, with 2 product records.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 91% of the 1,153 device enforcement events initiated in 2015 carry the same class.
Status: Terminated, terminated 18 Sep 2017. Initiation: voluntary: firm initiated. Elcam Medical, Inc. has 2 enforcement events on this register, with a median of 2 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Elcam Medical, Inc., Hackensack, NJ.
Reason for recall
"Punctured blister packages were detected during the packaging process at the manufacturing site. Potential for device contamination."
Distribution
"Texas, New Mexico and Pennsylvania"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2748-2015 | Elcam Medical Minimal Residual Volume Luer activated Swabbable stopcock (MRVLS) for pressure monitoring and intravenous fluid administration; Manufactured by: Elcam Medical ACAL, Israel. Sterile, Quantity 20. | 7,721,580 units | Class II | Terminated | 16 Sep 2015 |
| Z-2749-2015 | 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 | 248,100 | Class II | Terminated | 16 Sep 2015 |
Context
Other enforcement events for Elcam Medical, Inc.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 2 Feb 2017 | Elcam Minimal Residual Volume Luer-activated Swabable-stockcock (MRVLS) 4w gxl:w1/r rbls Product Usage: indicated for fl (76446) | Device | Class II | 1 |
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Punctured blister packages were detected during the packaging process at the manufacturing site. Potential for device contamination."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Texas, New Mexico and Pennsylvania"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 18 Sep 2017. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.