Baxter 2C4031 - Irrigation Arthroscopy Set w/ 4 99" Leads Sterile 12/Ca
Four-Lead Arthroscopic Irrigation Set, 2.5 (99") long for use with ARTHROMATIC plastic containers, Sterile, Nonpyrogenic, 12 EA/CS
Four Lead Arthroscopic Irrigation Sets with ARTHROMATIC Plastic Containers
- Sterile, nonpyrogenic
- Do not use if product has been previously opened or damaged.
- Use aseptic technique
- Single use only; do not resterilize
- Rx only. For safe and proper use of these devices, please refer to the Instructions for Use.
- Caution: These products contain natural rubber latex which may cause allergic reactions.
Directions: Use aspetic technique
1. Protectors
Remove as required.
2. Spikes
Closre all clamps(3). Insert spikes into solution containers.
3. Clamp
Open all uper clamps. Prime both Y-leads; gently squeeze the containers as required. Invert chamber (4) and open lower clamp to fully prime set. Tap (4) to expel air bubbles. Close three upper clamps.
4. Chamber
5. Latex Tubing
Attach tubing to instrument. Open lower clamp(3) and regulate flow with instrument.
Note: Before solution is empty, open clamp on another lead and close clamp below empty container. Single use only. Don not resterilize.
Caution:
- This product contains Natural Rubber Latex Which May Cause Allergic Reactions.
- Rx only.
Device Characteristics
| What MRI safety information does the labeling contain? | Labeling does not contain MRI Safety Information |
| Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437): | Yes |
| Device labeled as "Not made with natural rubber latex": | No |
| For Single-Use: | Yes |
| Prescription Use (Rx): | Yes |
| Over the Counter (OTC): | No |
| Kit: | No |
| Combination Product: | No |
| Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P): | No |
Sterilization
| Device Packaged as Sterile: | Yes |
| Requires Sterilization Prior to Use: | No |
Pyrogen-free
Pyrogen is any substance that causes a fever. The most commonly thought of pyrogens are bacterial endotoxins and exotoxins, although the host body (human or animal) can also produce pyrogens. The most commonly assayed for pyrogen is lipopolysaccharide, or LPS. It is a component of the bacterial wall of Gram-negative bacteria and is released upon breakdown of the cell wall or bacterial cell lysis. Pyrogen-free products are manufactured in settings that prevent the deposition of bacteria and other agents on the products.
