Device recall: Safety-Deluxe Lumbar Puncture Tray, Catalog # 974 Product Usage: Surgical procedure
Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables (Hauppauge, NY) initiated this device recall on 27 Jun 2017; FDA lists 7 product records under event 78950, classified Class II.
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. 93% of the 1,091 device enforcement events initiated in 2017 carry the same class.
Status: Terminated, terminated 27 Jul 2020. Initiation: voluntary: firm initiated. Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables has 2 enforcement events on this register, with a median of 7 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
Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables, Hauppauge, NY.
Reason for recall
"BD SafetyGlide Needle 22GA 1-1/2 inch may contain the presence of loose polyprophylene foreign matter above release specification."
Distribution
"US Nationwide Distribution"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0540-2018 | Safety-Deluxe Lumbar Puncture Tray, Catalog # 974 Product Usage: Surgical procedure | 470 cases | Class II | Terminated | 14 Feb 2018 |
| Z-0541-2018 | Safety-Deluxe Basic Soft Tissue Biopsy Tray without Biopsy Needle, Catalog # 977 Product Usage: Surgical procedure | 28 cases | Class II | Terminated | 14 Feb 2018 |
| Z-0542-2018 | Safety-Deluxe Lumbar Puncture Tray, Catalog # 975 Product Usage: Surgical procedure | 82 cases | Class II | Terminated | 14 Feb 2018 |
| Z-0543-2018 | Safety Deluxe Bone Marrow Biopsy/ Aspiration Tray with Biopsy Needle and Aspiration Needle Sterile, Catalog # 985 Product Usage: Surgical procedure | 5 cases | Class II | Terminated | 14 Feb 2018 |
| Z-0544-2018 | Laceration Tray, Catalog # 1892R1 Product Usage: Surgical procedure | 75 cases | Class II | Terminated | 14 Feb 2018 |
| Z-0545-2018 | Lumbar Puncture Tray, Catalog # 1862 Product Usage: Surgical procedure | 1037 in total | Class II | Terminated | 14 Feb 2018 |
| Z-0546-2018 | Safety Deluxe Bone Marrow Biopsy/Aspiration Tray, Catalog # 986 Product Usage: Surgical procedure | 15 cases | Class II | Terminated | 14 Feb 2018 |
Context
Other enforcement events for Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 15 Nov 2016 | CARPAL TUNNEL PACK, Surgical Instrument Tray, REF/Catalog No. 3366, STERILE, Rx Only -- busse Hospital Disposables Haupp | Device | Class II | 3 |
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "BD SafetyGlide Needle 22GA 1-1/2 inch may contain the presence of loose polyprophylene foreign matter above release specification."
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: "US Nationwide Distribution"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 27 Jul 2020. "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.