Kendall Healthcare Products, Mansfield, Massachusetts, delivered recall notices via Fedex the week of April 13, 1998, to all of it's direct sale customers, wholesalers, hospitals,clinics, and home care suppliers. Subsequent to that notification, another brand name for this product, Professional Medical Products, Greenwood, SC, was found for sale at the wholesale level by the FDA. FDA's audit checks also have found some direct accounts who reportedly failed to receive Kendall's notification and some hospitals which failed to provide the recall message to all departments leading to recalled stocks remaining in one or more multiple locations within the facility. Based on this information Kendall will shortly be issuing an additional notice to all of its direct accounts, advising them of the Professional Medical Products brand and again requesting recovery of all codes, as identified in the following summary of the recall, down to the user level, whether institution or for home use. Your support in disseminating this information is important in the interest of consumer safety.

Products affected include:

BRAND NAME	PRODUCT CODE	SIZE	EXP DATE
1-Kendall brand	5251	3 mL vial	3/98 to 3/00
2-Kendall brand	5257	5 mL vial	5/98 to 1/00
3-Umeco brand	PR 5251	3 mL vial	10/99
4-Westmed brand	0453	1.5 mL vial
5-Professional Medical Products brand (Greenwood, SC)	5257	5 mL vial	5/98 to 1/00
6-Professional Medical Products brand (Greenwood, SC)	5251	3 mL vial	3/98 to 3/00
Lot Numbers affected: ALL LOTS

This recall is based on the findings of two lots of this product (714430 & 718315) containing the bacteria Ralstonia pickettii (formerly Burkholderia picketti, formerly Pseudomonas pickettii). While no injuries have been reported as a direct result of this contamination, Ralstonia picketti has been associated with sepsis and could be life-threatening to people with lung disease or certain immunocompromised patients.

All accounts who have received any of these products should immediately discontinue their use and cease distribution, as well as notify any users they have supplied with product of this same information, which would include those on home use status.

Health care providers, wholesalers, distributors, hospitals, or patients who have questions regarding the recall should contact David Olson of Kendall at 1-800-346-7197, extension 8530 or Cindy Provencher at extension 8155. Please report all adverse events to the same number or to MedWatch, the FDA Medical Products Reporting program at 1-800-FDA-1088, by fax at 1-800-FDA-0178, or by mail at the following address: MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD, 20857.

Return to Summary

---