FDA Medical Device Recalls (openFDA)
California Medical Laboratories Inc: CalMed Malleable Pericardial Sump, Single Use Only. Do Not Reuse. REF SU-20802; CalMed Laboratories, Costa Mesa, CA 92626
- Recall number
- Z-1177-2008
- Recalling firm
- California Medical Laboratories Inc
- Product
- CalMed Malleable Pericardial Sump, Single Use Only. Do Not Reuse. REF SU-20802; CalMed Laboratories, Costa Mesa, CA 92626
- Status
- Terminated
- Initiated
- 2008-01-24
- Posted
- 2008-06-11
- Terminated
- 2013-03-05
- Reason
- Fragment of material: The product may have a loose, stainless steel stringer flash located at the distal tip of the product.
- Root cause
- Process control
- Action
- CalMed emailed letters to consignees on 1/24/2008 notifying customers of the recall. The letter advises that that the following Medical Devices are subject to an immediate Voluntary Recall for Correction: Pericardial Sump (Catalog #SU-20601), Pericardial Sump (Catalog #SU-20602), and Malleable Pericardial Sump (Catalog #SU-20802). It is asked that further distribution or use of any remaining product should cease immediately. Where appropriate, the firm asks that consignees notify their own customers who received the product of the same. The Product is being recalled due to a potentially loose, stainless steel stringer flash located at the distal tip of the Product. Customers are asked to contact the firm's Quality Assurance Manager immediately for purposes of issuing a Returned Goods Authorization and coordinating the return of the Subject Medical Devices such that they may be inspected and nonconforming product removed. A response is requested via e-mail.
- Quantity
- 31,124 units of all models
- Distribution
- Worldwide Distribution - USA, Turkey, Brazil, Germany, Italy, Spain, Philippines, South Africa, Japan, Israel, Saudi Arabia, United Arab Emirates, India, Ireland, China, Hungary, Poland, Taiwan, Belgium, Pakistan, Lithuania, Greece, Canada, Syria, Israel, Austria, Denmark, Bangladesh, Costa Rica, Mexico, Spain, and Sultanate of Oman.
- Lot, serial or model codes
- Catalog Number SU-20802, Lot Numbers: S040870 S041515 S050537 S050907 S050919 S051982 S052118 S052325 S060056 S060158 S060909 S060924 S070307 S071047 S071462NS S071463 S071620 S071754 and S071985.
- 510(k) numbers
- ["K982891"]
- PMA numbers
- not on file
- Product code
- DTS
- Firm FEI
- 1000135553
- Firm city
- Costa Mesa
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28