10 Recent Pain Management & Anesthesia Device Recalls
1. Nationwide Recall Issued for Lot of Hydromorphone Injection. Hospira issued in late August a voluntary nationwide recall of one lot of Hydromorphone Injection. A single complaint reported that one Carpuject contained more than the 1mL labeled volume. If opioid pain medications, such as Hydromorphone, are overdosed, consequences could be life-threatening respiratory depression, low blood pressure and reduced heart rate.
2. Recall Issued for Hospital Injectable Anesthesia Product. The FDA issued a nationwide recall of three lots of Hospira's Propofol Injectable Emulsion in August. The affected product, which is packaged in vials and used for induction of anesthesia, was distributed to wholesalers and direct customers from September 2011 through February 2012.
3. Covidien Initiates Voluntary Recall of Tracheostomy Tubes. Covidien has voluntarily issued a global recall of its Shiley reusable cannula, cuffed size 8 adult tracheostomy tubes. The recall was issued in response to reports of volume leakage and disconnection between the inner and outer cannulae. Only certain lots of the size 8 tubes are being recalled. Unused products should be returned to the company, while currently used products should be replaced as soon as clinically appropriate as determined by the patient's physician. If the physician advises leaving the tracheostomy tube in place, Covidien strongly encourages that the frequency of direct patient observation be increased.
4. St. Jude Medical Recalls Pain Management Implant. St. Jude Medical recalled the Eon and Eon Mini pain management implants in August after reports that they had to be removed from patients for battery issues. The devices were removed because batteries failed too soon or were overheated while recharging. St. Jude has announced steps to correct the issue with the battery supplier.
5. Johnson & Johnson Recalls Duragesic Pain Patches. Johnson & Johnson recalled more than 53,000 Duragesic pain relief skin patches in July. The company said that at least one patch was found to have small crystals of the potent active ingredient.
6. GE Ventilators Recalled for Anesthesia Overdose Risk. General Electric recalled its Aestiva/5 7900 Ventilator in July due to a potential safety issue that could result in an overdose of anesthesia. The ventilator's two vaporizers could deliver an anesthetic simultaneously, possibly causing low blood pressure, irregular breathing and a lowered heart rate. The discovery prompted a Class 1 recall of the devices.
7. MAQUET Initiates Recall of FLOW-i Anesthesia System. MAQUET Medical Systems announced in July the initiation of a Class I recall of select models of its FLOW-i anesthesia system. The recall of its C20, C30 and C40 FLOW-i anesthesia systems was related to a software problem for the switch used for changing between manual and automatic ventilation modes.
8. Hospira Recalls Opioid Cartridges. Hospira recalled in May one lot of pre-filled cartridges containing hydromorphone because the glass cartridges could contain too much medicine, the company said. The recall follows two reported complaints of a single "Carpuject" cartridge containing more than the amount of drug indicated on the product's label.
9. American Regent Recalls HCI Injection. American Regent announced in February a nationwide voluntary recall of its phenylephrine HCl injection after it found visible particles in some retained samples of this lot.
10. Novartis Recalls Drugs Due to Production Issues at Nebraska Plant. In January, Novartis recalled 1,645 lots of Excedrin, NoDoz, Bufferin and Gas-X medicines because a mix-up at the company's Lincoln, Neb., plant caused the potential inclusion of stray capsules or caplets from other products. The plant, which also made some opioid prescription painkillers for Endo Pharmaceuticals including Opana, Percocet and an extended-release version of morphine tablets, was shut down
Related Articles on Anesthesia:
Anesthesia Medical Group Looks to Expand With Investment From Excellere Partners
Anesthesia Business Consultants Releases EHR Meaningful Use Software
CMS Creates EHR Exemption for Anesthesiologists
© Copyright ASC COMMUNICATIONS 2012. Interested in LINKING to or REPRINTING this content? View our policies by clicking here.
To receive the latest hospital and health system business and legal news and analysis from Becker's Hospital Review, sign-up for the free Becker's Hospital Review E-weekly by clicking here.
- 7 Guidelines for Preparing a News Release About Surgery Center Accreditation
- Hiring Physicians: 6 Questions Providing Insight Into Candidates
- Physicians: Timeline for 2014 Deadlines to Remember
- Spotlight on MMX Healthcare: Developing Reliable, Affordable Tools for ASC Data Tracking & Management
- Hand Hygiene Story Roundup