Tego Connector, Item No. D1000, NM1000 The Tego Needle Free Access Device is intended for use as an accessory to a vascu
FDA device recall Z-0988-2017 · posted 2017-01-10 · Terminated
Recall details
- Recalling firm
- ICU Medical, Inc.
- Reason for recall
- ICU Medical Inc. has identified a potential risk of leaking with certain Tego Connector devices.
- Action taken
- The firm, icumedical, sent an "URGENT: Medical Device Recall Notification" letter dated 8/24/16 to all their customers. The letter describes the product, problem and actions to be taken. The customers were instructed to quarantine any affected devices; remove from use, return to ICU medical, Inc.; and complete and return the recall response form to ICU Medical via fax (801) 264-1755 or at recall@icumed.com (even if you do not have any affected product). Customers with questions are instructed to contact ICU customer service Monday through Friday between 8:30AM and 4:00PM Pacific Time, (866) 829-9025 and select option 8 or email the following: customerservice@icumed.com.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- FPA
- Quantity affected
- 476,600 units
- Distribution
- Worldwide Distribution-US: (Nationwide) and countries of: Saudi Arabia, Germany, Austria, Belgium, Estonia, Poland, Switzerland, Canada, Luxembourg, Netherlands, Bulgaria, Malaysia, Italy, Ireland, Gr
- Date initiated
- 2016-08-24
- Date posted
- 2017-01-10
- Date terminated
- 2017-07-07
- Location
- San Clemente, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TEGO, MODEL D1000 (K053106) | Icu Medical, Inc. | 2006-01-10 |