External Drainage System Collection Bag, REF: NT821732C, STERILEEO, Rx only

FDA device recall Z-0634-2024 · posted 2024-01-04 · Open, Classified

Recall details

Recalling firm

Natus Medical Incorporated

Reason for recall

Sterility assurance cannot be guaranteed for external drainage systems due to incomplete bioburden testing.

Action taken

On November 28, 2023, Natus issued a "Urgent Medical Device Recall" Notification to affected consignees via USPS. Natus asked consignees to take the following actions: 1. Immediately cease use of the affected System and quarantine any inventory until you receive the shipping instructions from Natus to return any System(s). 2) Please complete the enclosed form and return to FCA@Natus.com. You will receive shipping instructions from FCA@Natus.com 3) Adverse reactions or quality problems experienced with the use of the System should be reported to Natus and the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, or by fax. " Complete and submit the report Online at www.fda.gov/medwatch/report.htm " Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178 4) Replacement System(s) will be made available to you at no cost. Natus Technical Service will be in contact with you shortly to arrange for the provision of replacement System(s).

Root cause

Process change control

Status

Open, Classified

Product code

JXG

Quantity affected

2,686 units

Distribution

US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT

Date initiated

2023-11-28

Date posted

2024-01-04

Location

San Diego, CA

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