Food, drugs, devices › GETINGE US SALES LLC
Device recall: HEMASHIELD Knitted Double Velour Cardiovascular Fabric
FDA enforcement event 79536 is a device recall by GETINGE US SALES LLC of Wayne, NJ, initiated 3 Jan 2018 and classified Class II, with 1 product record.
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. 92% of the 1,074 device enforcement events initiated in 2018 carry the same class.
Status: Terminated, terminated 3 Jul 2018. Initiation: voluntary: firm initiated. GETINGE US SALES LLC has 9 enforcement events on this register, with a median of 1 product record 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
GETINGE US SALES LLC, Wayne, NJ.
Reason for recall
"A probable mislabeling of the product: a different-sized product is referenced on the product packaging label (i.e. 2.5 cm (width) x 7.6 cm (length)) while the actual product inside the box is 2.5 cm (width) x 15 cm (length)."
Distribution
"FL"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1172-2018 | HEMASHIELD Knitted Double Velour Cardiovascular Fabric | 1 | Class II | Terminated | 4 Apr 2018 |
Context
Other enforcement events for GETINGE US SALES LLC
All 9 events for GETINGE US SALES LLC
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "A probable mislabeling of the product: a different-sized product is referenced on the product packaging label (i.e. 2.5 cm (width) x 7.6 cm (length)) while the actual product inside the box is 2.5 cm (width) x 15 cm (length)."
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: "FL"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 3 Jul 2018. "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.