FDA Medical Device Recalls (openFDA)
Arrow International Inc: PEDIATRIC JUGULAR PUNCTURE KIT/Product SKU (Code) AK-04150-E Pediatric jugular puncture kit
- Recall number
- Z-1345-2011
- Recalling firm
- Arrow International Inc
- Product
- PEDIATRIC JUGULAR PUNCTURE KIT/Product SKU (Code) AK-04150-E Pediatric jugular puncture kit
- Status
- Terminated
- Initiated
- 2010-10-29
- Posted
- 2011-02-17
- Terminated
- 2012-09-29
- Reason
- Sterility may be compromised.
- Root cause
- Other
- Action
- Arrow International, Inc. sent an URGENT MEDICAL DEVICE RECALL letter dated October 29, 2010, to all affected customers. The letter identified the products, the problem, and the action to be taken by the customer. Customers were instructed to quarantine the product. If they had no affected product in stock, check the appropriate box on the Recall Acknowledgement & Stock Status Form and fax the form to Arrow's Customer Service fax number 800-343-2935. If they had affected stock, immediately quarantine the product and contact Arrow Customer Service at 800-523-8446 for a Return Authorization Number. If customers wished to return product for replacement, they were to consult their sales representative or Arrow Customer Service for information on product availability, substitutability, and lead times. Complete the enclosed Recall Acknowledgement & Stock Status Form and immediately fax the compoleted form to Arrow, Fax number 800-343-2935, Attn: Customer Service. Return any affected product freight collect, along with the original completed Recall Acknowledgement & Stock Status Form to: Arrow International, Inc. 312 Commerce Place Aheboro, NC 27203 Attn: Asheboro Quality Assurance Manager. For any questions regarding this recall call 800-523-8446.
- Quantity
- 134,810 units
- Distribution
- Worldwide Distribution -- United States - all 50 States, and the countries of Canada, South America, China, South Africa, Australia, Puerto Rico, Philippines, Singapore, South Korea, New Zealand, Mexico, Japan, India, Indonesia, Bahamas, Taiwan, Thailand, Finland, France, Cyprus, Czech Republic, Belgium, Germany, Ireland, Italy, Latvia, Netherlands, Poland, Slovakia, Spain, Bahamas, Costa Rico, Dominican Republic, Ecuador, Guatamala and the United Kingdom.
- Lot, serial or model codes
- Lot Numbers: RF0022667, RF0033740, RF0046478, RF0060733, RF0077188, RF0088407, RF5096037, RF5106234, RF5107292, RF5118200, RF5118780, RF5120565, RF6011373, RF6022682, RF6034425, RF6045659, RF6046109, RF6056924, RF6068239, RF6070321, RF6080609, RF6080850, RF6081520, RF6081708, RF6104136, RF6104601, RF6115551, RF6116665, RF6126992, RF6127587, RF7018408, RF7019248, RF7019349, RF7020641, RF7029585, RF7031002, RF7032409, RF7054068, RF7054442, RF7066512, RF7077049, RF7077980, RF7088148, RF7089033, RF7090321, RF7101971, RF7102066, RF7102169, RF8016471, RF8016662, RF8017377, RF8020057, RF8020145, RF8032058, RF8043583, RF8044115, RF8057399, RF8060575, RF8069060, RF8071107, RF8084932, RF8107598, RF8108167, RF8122713, RF9016397, RF9028165, RF9030309, RF9031619, RF9042926, RF9043901, RF9056771, RF9069749, RF9073047, RF9084363, RF9086547, RF9100268, RF9109832, RF9114301 and RF9126957.
- 510(k) numbers
- ["K820009"]
- PMA numbers
- not on file
- Product code
- DQY
- Firm FEI
- 3015859709
- Firm city
- Reading
- Firm state
- PA
- 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
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
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