Ross Products Division Abbott Laboratories
Columbus, OH
Ross Products Division Abbott Laboratories appears in FDA device records in Columbus, OH. FDA records list no 510(k) clearances, no PMA records and no registered establishments. As of , FDA records show 88 recalls for this company.
FDA records held for this company
- 510(k) clearances
- 0
- PMA records
- 0
- Recall records
- 88
- Registered establishments
- 0
FDA records under these names
1 nameFDA records resolved to Ross Products Division Abbott Laboratories carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Abbott Nutrition, Abbott Laboratoriesrecall
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
No FDA product codes recorded against this company.
Recall records
Showing 25 of 88| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2252-2009 | Flexiflo Quantum Enteral Pump Model # 50596, 50598 and 59322. The Flexiflo Quantum enteral pump is a medical device that is used to deliver enteral nutrition products to tube-fed patients. The pumps are generally used in hospitals, nursing homes, health care institutions and home care. | The firm initiated this voluntary recall because some of its Flexiflo Quantum Enteral Pumps, have a 110-volt AC power cord plug that may crack or fail. This potential power cord plug failure may cause electrical shock and/or a delay in feeding that could represent a potential health and safety risk. | Terminated | ||
| Z-1142-2007 | The Companion ClearStar Pump System, for enteral feeding. | The transducer adapter bracket on the pump could crack or break and potentially result in under delivery of the enteral product. | Terminated | ||
| Z-1141-2007 | Embrace Enteral Pump | Continued use of the pump may cause the door pivot point on the back of the pump to crack or break. This will cause the pump to shut down and stop the initiation of enteral feeding. | Terminated | ||
| Z-0888-2007 | Patrol enteral pump set with piercing pin, list #520540. | The enteral pump set may have a 1-3 mm slit in the silicone tubing located between the blue connector and the stretch band Safe-T-Valve. | Terminated | ||
| Z-0570-05 | Flexiflo Quantum Enteral Pump | Pumps were manufactured with an incorrect circuit board that may cause an increase in the feed rate and flush frequency of fluids. | Terminated | ||
| Z-0703-04 | Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 24 Fr., 4.5 cm length, Item Numbers: 54230 and 55725. | The balloons may be defective as indicated by an increased number of early balloon failures, which may result in tube displacement from patient. | Terminated | ||
| Z-0702-04 | Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 24 Fr., 4.0 cm length, Item Number: 55723. | The balloons may be defective as indicated by an increased number of early balloon failures, which may result in tube displacement from patient. | Terminated | ||
| Z-0701-04 | Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 24 Fr., 3.5 cm length, Item Numbers: 54226 and 55721. | The balloons may be defective as indicated by an increased number of early balloon failures, which may result in tube displacement from patient. | Terminated | ||
| Z-0700-04 | Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 24 Fr., 3.0 cm length, Item Numbers: 54224 and 55719. | The balloons may be defective as indicated by an increased number of early balloon failures, which may result in tube displacement from patient. | Terminated | ||
| Z-0699-04 | Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 24 Fr., 2.7 cm length, Item Numbers: 54222 and 55717. | The balloons may be defective as indicated by an increased number of early balloon failures, which may result in tube displacement from patient. | Terminated | ||
| Z-0698-04 | Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 24 Fr., 2.5 cm length, Item Numbers: 54220 and 55715. | The balloons may be defective as indicated by an increased number of early balloon failures, which may result in tube displacement from patient. | Terminated | ||
| Z-0697-04 | Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 24 Fr., 2.3 cm length, Item Numbers: 54218 and 55713. | The balloons may be defective as indicated by an increased number of early balloon failures, which may result in tube displacement from patient. | Terminated | ||
| Z-0696-04 | Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 24 Fr., 2.0 cm length, Item Number: 55711. | The balloons may be defective as indicated by an increased number of early balloon failures, which may result in tube displacement from patient. | Terminated | ||
| Z-0695-04 | Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 24 Fr., 1.7 cm length, Item Numbers: 54214 and 55708. | The balloons may be defective as indicated by an increased number of early balloon failures, which may result in tube displacement from patient. | Terminated | ||
| Z-0694-04 | Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 24 Fr., 1.5 cm length, Item Number: 55706. | The balloons may be defective as indicated by an increased number of early balloon failures, which may result in tube displacement from patient. | Terminated | ||
| Z-0693-04 | Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 20 Fr., 4.5 cm length, Item Numbers: 54210 and 55704. | The balloons may be defective as indicated by an increased number of early balloon failures, which may result in tube displacement from patient. | Terminated | ||
| Z-0692-04 | Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 20 Fr., 4.0 cm length, Item Numbers: 54208 and 55702. | The balloons may be defective as indicated by an increased number of early balloon failures, which may result in tube displacement from patient. | Terminated | ||
| Z-0691-04 | Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 20 Fr., 3.5 cm length, Item Numbers: 54206 and 55700. | The balloons may be defective as indicated by an increased number of early balloon failures, which may result in tube displacement from patient. | Terminated | ||
| Z-0690-04 | Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 20 Fr., 3.0 cm length, Item Numbers: 54204 and 55698. | The balloons may be defective as indicated by an increased number of early balloon failures, which may result in tube displacement from patient. | Terminated | ||
| Z-0689-04 | Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 20 Fr., 2.7 cm length, Item Numbers: 54202 and 55696. | The balloons may be defective as indicated by an increased number of early balloon failures, which may result in tube displacement from patient. | Terminated | ||
| Z-0688-04 | Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 20 Fr., 2.5 cm length, Item Numbers: 54200 and 55694. | The balloons may be defective as indicated by an increased number of early balloon failures, which may result in tube displacement from patient. | Terminated | ||
| Z-0687-04 | Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 20 Fr., 2.3 cm length, Item Number: 55692. | The balloons may be defective as indicated by an increased number of early balloon failures, which may result in tube displacement from patient. | Terminated | ||
| Z-0686-04 | Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 20 Fr., 2.0 cm length, Item Numbers: 54196 and 55690. | The balloons may be defective as indicated by an increased number of early balloon failures, which may result in tube displacement from patient. | Terminated | ||
| Z-0685-04 | Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 20 Fr., 1.7 cm length, Item Numbers: 54194 and 55688. | The balloons may be defective as indicated by an increased number of early balloon failures, which may result in tube displacement from patient. | Terminated | ||
| Z-0684-04 | Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 20 Fr., 1.5 cm length, Item Numbers: 54192 and 55684. | The balloons may be defective as indicated by an increased number of early balloon failures, which may result in tube displacement from patient. | Terminated |
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Ross Products Division Abbott Laboratories edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain